New eye drug aims to block two causes of vision loss at once

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must meet all the following criteria to be eligible for this study: 1. Signed Informed Consent 2. Age ≥50 and ≤89 years on Day 1/Baseline 3. Treatment-naive CNV secondary to AMD (nAMD), with or without geographic atrophy in the study eye. a. Patients with neovascular AMD alone include: i. All MNV subtypes (Type 1, Type 2, Type 3, PCV). (Spaide 2020) ii. Subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity identified by FA or OCT (where CNV activity is defined as showing evidence of subretinal fluid, subretinal hyper reflective material, or leakage) iii. A total lesion size (including blood, atrophy, fibrosis, and neovascularization) of ≤ 9 disc areas on FA iv. A CNV component area of ≥50% of the total lesion size on FA b. Participants with nAMD and underlying and quantifiable geographic atrophy (GA) will be included if the following criteria are met: i. Total GA area on FAF between ≥2.5mm² and ≤17. mm² (\~1-7 disc areas), If GA is multifocal, at least one lesion ≥1.25 mm² (\~0.5 disc area). ii. GA lesion must be located within 1500 μm of the foveal center but not involving the fovea 4. BCVA of 70 to 24 letters, inclusive (20/40 to 20/320 approximate Snellen equivalent), using the ETDRS protocol (see the BCVA manual for additional details) at Screening and Baseline in the study eye 5. Participants with confirmed underlying geographic AMD in the study eye at Screening or Baseline will be included in the study if all of the other criterion are met 6. Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis in the study eye 7. Male participants engaged in a sexual relationship with a woman of childbearing potential must be willing to use a medically accepted method of contraception from the duration of their participation in the study. 8. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment i. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous 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 ii. Examples of acceptable contraceptive methods include bilateral tubal ligation, male sterilization; hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices; and copper intrauterine devices iii. Contraception methods that do not result in a failure rate of \<1% per year such as male or female condom with or without spermicide; and cap, diaphragm, or sponge with spermicide are not acceptable iv. 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 participants. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception Exclusion Criteria: * Participants who meet any of the following criteria will be excluded from study entry: 1. CNV due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis in either eye. 2. Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye. 3. Presence at screening of central serous chorioretinopathy in the study eye. 4. Retinal pigment epithelial tear involving the macula. 5. On FA/CFP/OCT/FAF: Inactive nAMD in the study eye: 1. Subretinal hemorrhage of \>50% of the total lesion area and/or that involves the fovea 2. Fibrosis of \>50% of the total lesion area and/or that involves the fovea 3. Cystic degeneration (persistent intraretinal fluid or tubulations unresponsive to treatment) 6. Any concurrent intraocular condition (e.g., amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study in the study eye. 7. Current vitreous hemorrhage at Screening and Day 1 in the study eye. 8. Uncontrolled glaucoma, defined as intraocular pressure \>25 mmHg while on two or more pressure lowering medications and/or will require surgical intervention or laser treatment during the study in the study eye. 9. Spherical equivalent of refractive error demonstrating more than 8 diopters of myopia in the study eye. 10. For participants who have undergone prior refractive or cataract surgery, the preoperative refractive error should not have exceeded -8 diopters of myopia in the study eye. 11. Any prior or concomitant treatment for CNV, GA or vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment (e.g., anti-VEGF, complement therapy, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or ocular surgical intervention in the study eye. 12. Any cataract surgery or treatment for complications of cataract surgery with steroids or YAG (yttrium-aluminum-garnet) laser capsulotomy within 3 months prior to Screening in the study eye 13. Any other intraocular surgery or intervention (e.g., pars plana vitrectomy, glaucoma surgery, including minimally invasive glaucoma surgery \[MIGS\], corneal transplant, or radiotherapy) 14. Non-functioning non-study eye, defined as either: 1. BCVA of hand motion or worse 2. No physical presence of non- study eye (i.e., monocular) 15. History of idiopathic or autoimmune-associated uveitis in either eye 16. Active ocular inflammation or suspected or active ocular or periocular infection in either eye at the Screening visit. 17. Any major illness or major surgical procedure within 1 month before screening 28 Clinical Protocol OCUL101-002 Shenzhen Oculgen Biomedical Technology Co., Ltd. Protocol OCUL101-002, Version 2.0 Date: 12March2026 18. Active cancer within the 12 months prior to Screening except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of \< 6 and a stable prostate-specific antigen for \> 12 months 19. Requirement for continuous use of any medications and treatments indicated in Section 6.6.1, Prohibited Therapy 20. Systemic treatment for suspected or active systemic infection at Screening. a. Ongoing use of prophylactic antibiotic therapy may be acceptable if approved after discussion with the Medical Monitor 21. Uncontrolled blood pressure, defined as systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg while a participant is at rest at the Screening visit. a. If a participant's initial reading exceeds these values, a second reading may be taken later on the same day or on another day during the screening period. If the participant's blood pressure is controlled by antihypertensive medication, the participant should be taking the same medication continuously for at least 30 days prior to Screening. 22. Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Screening. 23. History of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator 24. Pregnancy or breastfeeding, or intention to become pregnant during the study a. Women of childbearing potential must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test. 25. History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of OCUL101 or aflibercept injections, study-related procedure preparations (including fluorescein), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study 26. Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals), including gene therapy or cell therapies, within 3 months prior to Screening.