Research Study Full Eligibility Criteria
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Neovascular Age-Related Macular Degeneration (nAMD or Wet AMD)
Ocular SOL-R / OTX-TKI-2023-AMD-303 / Ocular Therapeutix, Inc.
Inclusion Criteria
At Screening Visit 1:
- At least 50 years of age or older at Day 1.
- Eligible to receive intraocular aflibercept therapy as per the FDA labels for the treatment of nAMD (Note: non-exudative CNV secondary to AMD is exclusionary)
- Have adequate ocular media and adequate pupillary dilation in the study eye to permit good quality fundus imaging.
- Treatment naïve juxtafoveal and/or subfoveal CNV secondary to nAMD with leakage involving the fovea prior to Screening, or have a diagnosis of nAMD in study eye within 4 months prior to or at screening and received 1 to 3 consecutive monthly (approximately every 4 weeks) anti-VEGF injections of any type (except Beovu®) with last injection approximately 4 weeks prior to Screening, with a CNV lesion of any type (i.e., predominantly classic, minimally classic, or occult [including polypoidal choroidal vasculopathy and retinal angiomatous proliferation]) that exhibits all of the following characteristics in the study eye at Screening as confirmed by CRC: (Note: For subjects who screen failed in the OTX-TKI-2023-AMD-301 study, or recently diagnosed with nAMD [within 4 months prior to screening], historical images could be used for eligibility assessment.)
- For treatment naïve or experienced study eye, A total lesion size (including blood, atrophy, fibrosis, and neovascularization) of ≤9-disc areas on fundus FA. Any macular hemorrhage should be resolved by Baseline (Day 1) prior to randomization, as assessed by the Investigator.
- For treatment naïve study eye, the CNV component area must be ≥50% of the total lesion size on FA
- For treatment naïve or experienced study eye, presence of active CNV confirmed on FA (evidence of leakage)
- For treatment naïve study eye, CNV exudation confirmed on SD-OCT (presence of intraretinal and/or subretinal fluid measured from ILM to RPE layer).
- Have a BCVA ETDRS letter score of at least 34 or greater (approximately 20/200) in the study eye at Screening.
- Have a CSFT ≤350 μm (measured from ILM to RPE layer) in the study eye at Week -12, confirmed by CRC.
- Have a CSFT ≤ 350 μm (measured from ILM to RPE layer) in the study eye at Week -8 and < 35 μm increase from the lowest CSFT at any prior visits, confirmed by a CRC.
- Are female who is postmenopausal for at least 12 months prior to Screening or surgically sterile; or male or female of childbearing potential willing to use two forms of adequate contraception from Screening until they exit the study.
- Are able and willing to comply with all study requirements and visits.
- Have provided written informed consent.
Exclusion Criteria
Individuals are not eligible for study participation if they meet any of the following criteria:
- Presence of a disease other than CNV due to AMD in the study eye that could affect vision or safety assessments.
- Monocular subject or BCVA score of <20 ETDRS letters or 20/400 in fellow eye at Screening.
- Have evidence of a scar, fibrosis, or atrophy of >50% of the total lesion in the study eye.
- Currently or previously treated with Syfovre® or Izervay™ for geographic atrophy in study eye. For fellow eye, treatment with Syfovre® or Izervay™ for geographic atrophy within 3 months prior to Screening.
- Have previous laser photocoagulation or verteporfin photodynamic therapy (PDT) to the macula in the study eye.
- Have history of intraocular surgery in the study eye including:
- cataract surgery or keratorefractive surgery (laser-assisted in-situ keratomileusis [LASIK], photorefractive keratectomy [PRK], etc.) or any anterior segment surgery within 3 months of Screening or
- have expectation of penetrating keratoplasty, vitrectomy, cataract surgery, or LASIK or any other intraocular surgery during the study period or
- have a history of vitreoretinal surgery (including vitrectomy) or other ocular surgeries including scleral buckle or glaucoma filtering/shunt surgery.
- Have received gene therapy treatment or ranibizumab port delivery system (PDS, [Susvimo™]) for any reason in either eye.
- Aphakia or sulcus intraocular lens in the study eye.
- Have a history of significant ocular infection (bacterial, viral, or fungal) within the previous 3 months, or history of herpetic ocular diseases (including herpes simplex virus, varicella zoster, or cytomegalovirus retinitis) or toxoplasmosis gondii or chronic/recurrent inflammatory eye disease (i.e., scleritis, uveitis, corneal edema) in either eye.
- Have evidence of a rhegmatogenous retinal detachment or visually significant/severe epiretinal membrane, vitreomacular traction syndrome, macular hole, tear of the retinal pigment epithelium in the macula, or other macular pathology deemed visually significant by the Investigator in the study eye.
- Have a history of or presence of vitreous hemorrhage due to any other cause except posterior vitreous detachment in the study eye. Subject is still eligible if history of past hemorrhagic posterior vitreous detachment has resolved.
- Have advanced glaucoma with uncontrolled IOP ≥25 mmHg despite IOP-lowering treatment in the study eye.
- Have presence of other causes of CNV, e.g., pathologic myopia (spherical equivalent ≥ –8 diopters, or axial length of 26 mm or more), choroidal rupture, ocular histoplasmosis syndrome, or multifocal choroiditis in the study eye.
- Have any current systemic or ocular treatment in the study eye with TKIs or systemic treatment with anti-VEGF agents.
- Have ocular malignancy including choroidal melanoma in either eye.
- Are receiving concurrent treatment with medications known to be toxic to the retina, lens, or optic nerve (e.g., chlorpromazine, phenothiazines, tamoxifen, hydroxychloroquine, pentosan polysulfate etc.).
- Have a need for chronic therapy with systemic, intraocular or peri-ocular, or topical ocular corticosteroids in the study eye (>7 days) or have known allergy to fluorescein (e.g., bronchospasm, rash, etc.), or to any component of the study products.
- Have symptomatic or unstable coronary artery disease, angina, congestive heart failure, or an arrhythmia requiring active procedural management (management with medications is permissible) within the last 30 days of the screening visit.
- Have uncontrolled hypertension (defined as >160/100 mmHg, despite anti-hypertensive treatment).
- Have a history of or presence of uncontrolled systemic disease or a debilitating disease (e.g., active malignancy within 2 years, Parkinson’s disease, dementia, liver failure, kidney failure requiring dialysis, progressive worsening of an inflammatory, autoimmune or pulmonary disease).
- Had a myocardial infarction or other cardiovascular event (e.g., stroke) within the previous 6 months.
- Have uncontrolled diabetes (defined as HbA1c >12%) despite treatment at Screening. Diabetic medication(s) could be adjusted if necessary and HbA1c should be repeated at Week -4 for eligibility assessment.
- Are female and pregnant or breastfeeding or intend to become pregnant during the study.
- Have participated in any study involving an investigational drug either in the US or outside the US within the past 30 days from Screening.
- Are an employee of the site that is directly involved in the management, administration, or support of the study, or an immediate family member of the same.
Daybreak / KS301P109 / Kodiak Sciences, Inc.
Ocular Inclusion Criteria
Where applicable, ocular inclusion criteria will be confirmed or assessed by the independent, masked image reading center.
- Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal, and extrafoveal lesions, or retinal angiomatous proliferations (RAP) lesions with a CNV component that affects the central subfield, as evidenced by FA or OCT in the Study Eye at Screening.
- The CNV area in the Study Eye must be at least 50% of total lesion size in FA at Screening.
- The lesion area in the Study Eye must be <30 mm2 (12-disc areas) and can include any CNV lesion subtype.
- Intra- and/or subretinal fluid affecting the central subfield of the Study Eye on OCT at Screening.
- BCVA ETDRS score between 78 and 25 letters (Snellen equivalent ~20/32 and 20/320) inclusive, in the Study Eye at screening and reconfirmed at Day 1.
- Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD. Only one eye per participant is eligible to participate in the study. If both eyes are eligible to become the Study Eye, the eye with worse BCVA at screening will be selected as the Study Eye. If both eyes are eligible and have the same BCVA, the decision of which eye to select as the Study Eye will be made by the Investigator.
General Inclusion Criteria
- Male or female ≥50 years of age.
- Capable of giving signed informed consent, as described in Appendix 1, which includes compliance with the protocols and restrictions listed in the informed consent form (ICF) and in this protocol.
- For women of childbearing potential (WOCBP): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 90 days after the last dose of study intervention.
- A woman is considered of childbearing potential if she is post-menarchal, has not reached a post-menopausal state (≥12 months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.
- Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices.
- Contraception methods that do not result in a failure rate of <1% per year such as cap, diaphragm, or sponge with spermicide, or male or female condom with or without spermicide, are not acceptable.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, as defined below:
- With female partners of childbearing potential, men must remain abstinent or use a condom and encourage their female partner to use one of the approved contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 120 days (30 days plus a 90-day spermatogenesis cycle) after the last dose of study intervention. Men must refrain from donating sperm during this same period.
- Ability and willingness to undertake all the scheduled visits and assessments.
Ocular Exclusion Criteria
Where applicable, ocular exclusion criteria will be determined by an independent, masked image reading center.
- BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).
- OCT CST > 900 microns at Screening or Day 1.
- Active or suspected ocular or periocular infection or inflammation in either eye at Screening or on Day 1.
- CNV secondary to other causes in the Study Eye, including pathologic myopia, angioid streaks, prior trauma, ocular histoplasmosis, or others.
- Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid, such as central serous chorioretinopathy.
- Fibrosis or atrophy of >50% of the lesion size and/or involving the foveal center of the Study Eye at Screening.
- Subretinal blood affecting the foveal center of the Study Eye and/or more than 50% of the lesion size at Screening.
- Retinal pigment epithelium tear or rip in the Study Eye at Screening or on Day 1.
- Any approved or investigational treatment for neovascular AMD (other than oral vitamin supplements) in the Study Eye at any time.
- Prior macular laser (e.g., thermal laser or photodynamic therapy laser) in the Study Eye.
- Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema (ME) or alter visual acuity during the study (e.g., vitreomacular traction, epiretinal membrane).
- History of cataract surgery and/or minimally invasive glaucoma surgery (MIGS) in the Study Eye within 2 months of screening.
- History of Yttrium-Aluminum Garnet (YAG) laser capsulotomy in the Study Eye within 2 months of screening.
- Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the Study Eye.
- History of glaucoma-filtering surgery (trabeculectomy or tube shunt) in the Study Eye.
- History of retinal detachment or treatment or surgery for retinal detachment in the Study Eye.
- History of uveitis in either eye.
- Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT or fundus photography.
- Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of Screening.
- Aphakia in the Study Eye.
- Prior vitrectomy in the Study Eye.
- Prior intraocular steroids in the Study Eye, or use of periocular steroids (sub-Tenons) within 2 months from Screening. Prior use of topical steroids is not exclusionary at any time.
- Current vitreous hemorrhage or history of vitreous hemorrhage in the Study Eye within 3 months of Screening.
- History of corneal transplant in the Study Eye.
- Insufficient OCT image quality in the Study Eye at Screening or Day 1, which impedes accurate image segmentation and grading.
General Exclusion Criteria
- Women who are pregnant or lactating or intending to become pregnant during the study.
- Women of child-bearing potential must have a negative urine pregnancy test result within 28 days prior to Day 1. If the urine pregnancy test is positive, it must be confirmed with a serum pregnancy test prior to Day 1.
- Uncontrolled blood pressure defined as a systolic value ≥180 mmHg or diastolic value ≥100 mmHg while at rest at screening or on Day 1.
- If a participant’s initial blood pressure measurement exceeds these values, up to two additional readings may be taken later the same day or on a different day during the screening period. If a participant’s blood pressure is controlled by antihypertensive medications, the participant must be on a stable medication regimen continuously for 21 days prior to Day 1.
- Kidney failure requiring renal transplant, hemodialysis or peritoneal dialysis or expected to require renal transplant, hemodialysis, or peritoneal dialysis during the study.
- Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure, or any acute coronary event.
- History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
- History of hypersensitivity to intravitreal agents such as aflibercept or ranibizumab or to any component of tarcocimab-ted, tabirafusp-ted, ophthalmic dye (fluorescein), dilating drops, or any of the anesthetic or antimicrobial preparations used during the study, as assessed by the Investigator.
- Active cancer within the 12 months prior to screening except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, and prostate cancer.
- Treatment with systemic anti-VEGF therapeutics within 90 days prior to screening.
- Participation in an investigational study within 30 days prior to the screening visit that involved treatment with any investigational drug (excluding vitamins and minerals) or investigational devices, except for non-therapeutic ophthalmic imaging devices.
Protocol AO / DRCR Retina Network / Jaeb Center for Health Research.
Individual-Level Criteria
Inclusion
Individuals must meet all of the following inclusion criteria to be eligible to participate in the run-in phase of the study:
- Age ≥ 50 years
- Have the capacity to consent on his/her own behalf and follow instructions
- Must understand English or Spanish
- At least one eye that meets the study eye criteria listed below
- Ability to cooperate with required visit procedures
- Able to successfully and independently complete at least one self-scanning session on the Home OCT device located at the enrolling clinical site
- Participant’s home has a table with a smooth, flat surface close to an electrical outlet to support placement of the Home OCT device for 2 years (device dimensions are 9.8” wide × 14.2” deep × 16.9” high)
- Able to set up the Home OCT device by themselves or with assistance from others in their household (device is 16 pounds without packaging, 17.8 pounds with packaging)
- Lives in an area with cell phone reception of 4G or above, or the location in which the Home OCT device will be placed has Wi-Fi connectivity (for the Home OCT data to be properly uploaded to the cloud)
- Has a telephone number (home or cell) for Notal to call and provide Home OCT assistance and reminders
- Participant is willing to perform once daily Home OCT monitoring tests for 2 years without significant interruption (such as travel of more than 14 days at a time)
- Patients who spend part of the year in a different location will be permitted to enroll in the study if another DRCR clinical site is located near their second home, and they are willing to be seen at that location during follow-up. Additionally, their second home must meet the requirements for Home OCT device use specified above.
Exclusion
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status that may preclude successful completion of follow-up)
- Known allergy or hypersensitivity to any component of the study drug or any drug used in the injection prep (including povidone iodine prep)
- Participation in an investigational trial that involved treatment within 30 days of screening with any drug that has not received regulatory approval for the indication being studied.
- The participant should not receive or use any other drug or device in the study eye that is not FDA approved during the study.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 2 years
- Women who are potential study participants should be questioned about the potential for pregnancy at baseline and prior to each injection. Women of childbearing potential will be required to have pregnancy testing or use an acceptable method of pregnancy prevention. Pregnancy test is required for all women of childbearing potential at screening. Investigator judgment is used to determine when a pregnancy test is needed during follow-up.
- Childbearing potential is defined as less than 12 months post-menopausal or not surgically sterile.
- Acceptable methods of pregnancy prevention are condom with spermicide, hormonal contraception, or IUDs.
- Participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 2 years
- Use of pentosan polysulfate, chloroquine, or hydroxychloroquine (Plaquenil®) within the last 5 years, or planned use during the next 2 years
- Use, or plan to use, any at-home device related to monitoring nAMD not provided by the study, including ForeseeHome®, within the next 2 years
- Potential participants currently using ForeseeHome® may be enrolled if they 378 agree to stop use prior to randomization.
Study Eye Criteria
Inclusion
- Best corrected E-ETDRS visual acuity ≥24 ETDRS letters (approximately 20/320 or better (Snellen))
- Previously untreated, active MNV lesion (i.e., any intraretinal or subretinal fluid on OCT) secondary to age-related macular degeneration
- MNV or sequelae of the MNV (i.e., pigment epithelium detachment, subretinal or sub-RPE hemorrhage, or subretinal, sub-RPE or intraretinal fluid) involving the foveal center
- ≥ 1 intermediate drusen (>63 microns) in either eye OR late AMD (MNV or macular atrophy) in the contralateral eye
Exclusion
- History of rhegmatogenous retinal detachment, macular hole, or lamellar hole
- History of vitrectomy
- YAG capsulotomy performed within 1 month prior to the baseline visit.
- History of trabeculectomy or Baerveldt or Ahmed tube for uncontrolled glaucoma
- Minimally Invasive Glaucoma Surgery (MIGS) devices are allowed
- History of retinal vein occlusion
- Previous treatment for MNV (intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent, or any other AMD therapy)
- Prior treatment with intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent or with macular laser for any indication
- Treatment with intravitreal corticosteroids within the last 6 months
- Current use of pegcetacoplan
- Intraocular surgery (including cataract surgery) within 4 months prior to the baseline visit, or anticipated within the next 6 months
- Active or recent (within 4 weeks) intraocular inflammation (grade trace or above)
- Any condition that may preclude adequate imaging of the macula (e.g., dense cataract or other media opacity, severe ptosis)
- The Notal Vision Monitoring Center must review the in-office Home OCT scan to confirm no pathology is affecting the quality of the image prior to randomization
- Fibrosis or macular atrophy involving the foveal center
- Epiretinal membrane distorting the foveal center
- Significant vitreomacular traction in the foveal center
- Aphakia
- MNV due to other causes, such as ocular histoplasmosis, central serous retinopathy, or pathologic myopia
- Retinal pigment epithelial tear involving the foveal center
- Current vitreous hemorrhage
- Polypoidal choroidal vasculopathy (PCV)
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
- High myopia; defined as 8 or more diopters of myopia or clinical evidence of high myopia
- Uncontrolled glaucoma
- Intraocular pressure must be<30 mmHg, with no more than one topical glaucoma medication, and no documented glaucomatous field loss for the eye to be eligible
- Diabetic retinopathy worse than diabetic retinopathy severity level 35
- Progressive retinal or other ocular diseases, such as amblyopia or ischemic optic neuropathy, which can affect visual acuity or are likely to affect visual acuity within the next 2 years
- Any concurrent retinal vascular disease such as that, in the opinion of the investigator, could require medical or surgical intervention during the 2-year follow-up period
Geographic Atrophy (GA)
Archer II / ANX007-GA-02 / Annexon, Inc.
Inclusion Criteria
Participants must meet ALL of the following criteria to be eligible to participate in this study. An independent Central Reading Center will confirm lesion eligibility prior to randomization.
- Fellow eyes treated with an approved anti-complement drug for GA for at least 4 weeks prior to study entry may continue treatment with no washout. Fellow eyes treated with an approved anti-complement drug for GA for fewer than 4 weeks should not be enrolled in the study. GA-treatment naive fellow eyes should, in the opinion of the Investigator, be unlikely to need treatment for GA in the fellow eye for at least the first year of the study.
- Participant must be at least 50 years of age at the time of signing the informed consent.
- Able and willing to participate in a 24-month study with monthly visits.
- Diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the independent Central Reading Center.
- The GA lesion must have the following characteristics as determined by the independent Central Reading Center based on assessment of FAF imaging at screening. If both eyes are confirmed to be eligible by the independent Central Reading Center, the determination of the study eye selection is in the opinion of the Investigator.
- Well-demarcated GA with a total area (baseline lesion size) ≥2.5 mm2 and ≤ 17.5 mm2.
- If GA is multifocal, at least one focal lesion must measure ≥1.25 mm2 with the overall aggregate area of GA as specified above in 5a.
- Presence of hyper autofluorescence, any pattern, in the junctional zone of the GA. Absence of hyper autofluorescence (i.e., pattern = none) is exclusionary.
- The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any peripapillary atrophy.
- Normal luminance BCVA of 45 to 83 letters using ETDRS charts (20/25 to 20/100 Snellen equivalent, inclusive). a. If BCVA at screening and baseline are different by 10 or more letters, the participant will be considered a screen failure at the baseline visit. Baseline BCVA must meet eligibility criteria. Sex and Contraceptive/Barrier Requirements or Female Participants
- A female participant is eligible if she is not pregnant or breastfeeding, and one of the following conditions applies:
- Is a woman of non-childbearing potential (WONCBP) (defined as having undergone surgical sterilization or being postmenopausal [i.e., greater than 50 years old with amenorrhea for at least 12 months without an alternative medical cause]). OR
- Is the WOCBP using a contraceptive method that is highly effective, with a failure rate of <1%, during the study intervention period and for at least 30 days after the last dose of study intervention.
- WOCBP must have a negative pregnancy test (PT) within 24 hours before the first dose of study intervention.
- The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Informed Consent
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
Exclusion Criteria
Participants are excluded from the study if ANY of the following criteria apply.
- Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (eg, plaquenil maculopathy) in either eye.
- Any evidence of CNV in the study eye: a. Any history of CNV of any cause based on medical history. b. Evidence of prior or active CNV or related findings (eg, retinal pigment epithelial rips or tears) based on FAF, spectral domain optical coherence tomography (SD-OCT) imaging, Intravenous fluorescein angiography (IVFA) and color fundus photo as assessed by the Central Reading Center.
- Spherical equivalent of -8.00 diopters (D) myopia or higher in the study eye.
- Uncontrolled glaucoma in the study eye (Intraocular pressure (IOP) >25 mmHg despite treatment with anti-glaucoma medication) or history of neovascular glaucoma.
- History of glaucoma filtration surgery, minimally invasive glaucoma surgery involving an implant, or vitrectomy surgery, or other procedure in the study eye that could affect drug distribution and/or clearance.
- History of uncomplicated cataract surgery less than 3 months prior to dosing in the study eye.
- Any ophthalmic condition that may require surgery during the study period in the study eye.
- Ocular trauma in the study eye within the preceding 6 months.
- Any active ocular/intraocular infection or inflammation in either eye (eg, blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, uveitis).
- History of idiopathic or autoimmune-associated uveitis in either eye.
- Any current or prior ocular disease, other than GA, that in the opinion of the Investigator could interfere with the conduct of the study including, but not limited to, insufficient pupil dilation, retinal or optic nerve disease, media opacity, or aphakia in the study eye. Prior/Concomitant Therapy
- History of any prior IVT treatment for any indication in the study eye.
- Any prior treatment for AMD in the study eye (eg, pharmacological, surgical, radiation, thermotherapeutic, or laser intervention), except oral supplements or minerals.
- Previous participation in any studies of investigational medications within 3 months or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Note: Clinical studies solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
- Known hypersensitivity to ANX007 or any of the excipients in the ANX007 solution (as described in the ANX007 Investigator’s Brochure (IB) Table 1) or other ANX molecules (e.g., ANX005).
- Known hypersensitivity to fluorescein.
- Active alcohol or substance abuse/dependence or any other reason that makes it unlikely that the participant will comply with study procedures.
- History of current systemic medical or psychiatric conditions or any other reason, including laboratory findings, that may, in the opinion of the Investigator, contraindicate the use of an investigational medication, affect interpretation of study results, preclude adherence to the study visit schedule, or safe participation in the study.
Active Studies – Not Currently Enrolling
Neovascular Age-Related Macular Degeneration (nAMD or Wet AMD)
Ocular SOL / OTX-TKI-2023-AMD-301 / Ocular Therapeutix, Inc.
Inclusion Criteria
At Screening Visit 1:
- Treatment naïve for nAMD in either eye at screening.
- Have macular choroidal neovascularization due to nAMD who have had visual loss or would be expected to develop visual loss during the course of the study.
- If foveal intraretinal and/or subretinal fluid is present on SD-OCT, it shall not exceed 500 µm (CSFT) as determined by Investigator.
- Are eligible to receive intraocular aflibercept therapy for the treatment of nAMD.
- Have a BCVA ETDRS letter score of at least 54 or greater (~ 20/80) in either eye.
- Have adequate ocular media and adequate pupillary dilation in the study eye to permit good quality fundus imaging.
- Are female who is postmenopausal for at least 12 months prior to screening or surgically sterile; or male or female of childbearing potential willing to use two forms of adequate contraception from screening until they exit the study.
- Are able and willing to comply with all study requirements and visits.
- Have provided written informed consent.
At Day 1:
- Are older than 50 years of age at Day 1.
- Have BCVA of at least 84 ETDRS letter score (~ 20/20 Snellen equivalent) at Day 1; OR have an increase of at least 10 ETDTS letters of BCVA from Screening (Visit 1) BCVA.
- Have a CSFT of 350 µm or less in study eye at Day 1 as determined by Investigator.
Exclusion Criteria
- Have presence of a disease other than CNVM due to AMD in the study eye that could affect vision or safety assessments.
- Monocular subjects or a BCVA score of 20/200 in fellow eye at screening.
- Have evidence of a scar, fibrosis, or atrophy of > 50% of the total lesion in the study eye.
- Currently or previously treated Geographic Atrophy in study eye.
- Have previous laser photocoagulation to the macula in the study eye.
- Have history of intraocular surgery including cataract surgery or keratorefractive surgery (LASIK, PRK, etc.) or any anterior segment surgery in the study eye within 6 months of screening or have expectation of penetrating keratoplasty, vitrectomy, cataract surgery, or LASIK or any other intraocular surgery during the study period in the study eye or have a history of vitreoretinal surgery (including vitrectomy) or other ocular surgeries including scleral buckle or glaucoma filtering/shunt surgery in the study eye.
- Have received gene therapy treatment or PDS in the fellow eye.
- Have aphakia in the study eye.
- Have a history of significant ocular infection (bacterial, viral, or fungal) within the previous 3 months, or history of herpetic ocular diseases (including herpes simplex virus, varicellazoster, or cytomegalovirus retinitis) or toxoplasmosis gondii or chronic/recurrent inflammatory eye disease (i.e., scleritis, uveitis, corneal edema).
- Have evidence of a rhegmatogenous retinal detachment or visually significant/severe epiretinal membrane, macular hole, tear of the retinal pigment epithelium in the macula, or other macular pathology deemed significant by the Investigator in the study eye.
- Have a history of or presence of vitreous hemorrhage in the study eye. Subject is still eligible if history of past hemorrhagic posterior vitreous detachment has resolved.
- Have advanced glaucoma or uncontrolled IOP ≥ 25 mmHg despite treatment.
- Have a history of receiving glaucoma filtration surgery in the study eye.
- Have presence of other causes of CNV, e.g., pathologic myopia (spherical equivalent ≥ –8 diopters, or axial length of 26 mm or more), choroidal rupture, ocular histoplasmosis syndrome, or multifocal choroiditis in the study eye.
- Have any current systemic or ocular treatment with TKIs or systemic treatment with antiVEGF agents.
- Have an ocular malignancy including choroidal melanoma in either eye.
- Are receiving concurrent treatment with medications known to be toxic to the retina, lens, or optic nerve (e.g., chlorpromazine, phenothiazines, tamoxifen, etc.).
- Have a need for chronic therapy with systemic, intravitreal, or topical ocular corticosteroids or have known allergy to fluorescein (e.g., bronchospasm, rash, etc.), or to any component of the study products.
- Have symptomatic or unstable coronary artery disease, angina, congestive heart failure, or an arrhythmia requiring active procedural management (management with medications is permissible) within the last 30 days of the injection of the implant.
- Have uncontrolled hypertension (> 160/100 mmHg, despite medical treatment).
- Have a history of or presence of uncontrolled systemic or debilitating disease.
- Had a myocardial infarction or other cardiovascular event (e.g., stroke) within the previous 6 months.
- Have uncontrolled diabetes as deemed by the Investigator.
- Are female and pregnant or breastfeeding or intend to become pregnant during the study.
- Have participated in any study involving an investigational drug either in the US or outside the US within the past 30 days.
- Are an employee of the site that is directly involved in the management, administration, or support of the study, or an immediate family member of the same.