Dry Age-related Macular DegenerationPhase 3NCT07770828
Phase 3 Study to Assess Efficacy, Safety & Tolerability of OCU410 For Geographic Atrophy Secondary to Dry AMD
A Phase 3 study testing OCU410 in people with Dry Age-related Macular Degeneration, run by Ocugen at 3 sites in United States.
Trial summary
This study is a Phase 3 multicenter, randomized, controlled, assessor blinded, adaptive study in which subjects will be randomized in a 2:1(OCU410: control) ratio to treatment arm or control arm Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dry Age-related Macular Degeneration
- What is being tested?
- OCU410
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Aug 2026to 30 Jul 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 55 years of age or older at consent.
- BCVA of ≥25 ETDRS letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen Equivalent) and ≤80 ETDRS Letters (20/25 Snellen Equivalent) in the study eye.
- Fundus autofluorescence (FAF) imaging shows: a)Total GA area ≥2.5 and ≤ 17.5 mm2 (1 to 7 disk areas [DA], respectively); b)If GA is multifocal, at least one lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 3a. c)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 areas of peripapillary atrophy.
- Subjects with history of CNV diagnosis (inactive) in the fellow eye for ≥2 years prior to Screening; stable and treated CNV treatment prior to screening (stable and inactive); no active exudation at screening (confirmed by imaging at the discretion of the investigator)
- Subjects who had prior treatment with an approved drug for AMD, e.g. Izervay® (avacincaptad pegol) or Syfovre® (pegcetacoplan injection) can be included, after a washout period of at least 3 months in study eye from screening visit. Subjects can receive an approved drug for AMD in the fellow eye, if required.
Who cannot join
- Previous treatment with a gene-therapy or cell therapy product.
- GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Plaquenil maculopathy. However, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e., paving stone degeneration).
- Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm, inability to fixate, uncontrolled glaucoma, advanced cataract, corneal abnormalities, medium haze, and other retinal pathologies.
- Any history or current evidence of exudative ("wet") AMD in the study eye including any evidence of retinal pigment epithelium rips, branch retinal artery or vein occlusion, corneal transplant, or evidence of neovascularization anywhere in the retina based on fluorescein angiogram. Subjects with active exudative CNV in the fellow eye will be exclude.
- Presence of double-layer sign on SD-OCT, suggestive of subclinical macular neovascularization.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Erie Retina Research
Erie, Pennsylvania, 16505
Bethany Scott, 814-737-0203, b.scott.research@pm.me
David Almeida, MD
- Recruiting
Valley Retina Institute
McAllen, Texas, 78503
Alfred Halder, 956-631-8875 ext. 1800, alfred.halder@eyeptcare.com
Andres Rodriguez, 956-631-8875 ext. 1167, andres.rodriguez@eyeptcare.com
- Not yet recruiting
associated Retina Consultants
Phoenix, Arizona, 85381
Mallory Mintert, 480-999-5458, Mallory.mintert@doctrials.com
Benjamin Bakall, MD
About this study
Official title: A Phase 3 Registrational Study To Assess The Efficacy, Safety, And Tolerability Of OCU410 For Geographic Atrophy Secondary To Dry Age-Related Macular Degeneration
This study is a Phase 3 multicenter, randomized, controlled, assessor blinded, adaptive study in which subjects will be randomized in a 2:1(OCU410: control) ratio to treatment arm or control arm
Read the detailed description
This study is a Phase 3 multicenter, randomized, controlled, assessor blinded, adaptive study in which subjects will be randomized in a 2:1(OCU410: control) ratio to either of the following arms:
Treatment arm (OCU410) study subjects will receive single subretinal injection of 200 µL, OCU410 in the study eye with the optimal dose (N=158)
Control arm (untreated) (N=79)
A total of 237 subjects will be enrolled in the study. Subjects who are enrolled in the untreated control group of the study will not receive any treatment. Subjects randomized to the treatment arm may receive a single subretinal injection of OCU410 in the study eye, provided they meet all treatment eligibility criteria. Subjects who are randomized to the control arm will not receive any intervention during the initial 52 weeks (12 Months) of the study.
- Conditions
- Dry Age-related Macular Degeneration
- Being tested
- OCU410
- Keywords
- Geographical Atrophy, Dry Age Related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCU410Biological
Subretinal Injection
| Study group | Role | What they receive |
|---|---|---|
| OCU410 | Experimental | OCU410 Single Sub Retinal Injection, 200 µL, 1×10^10 vg/eye Receives: Biological: OCU410 |
| Untreated Control Arm | No intervention | Control Arm (Untreated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change (slope) of square root-transformed GA lesion area from baseline to Month 12
Rate of change (slope) of square root-transformed GA lesion area (√mm²/year) from baseline to Month 12 in treated eyes compared to control eyes as assessed by fundus autofluorescence (FAF) measurements
Measured: Month 12
Secondary outcomes (2)
Proportion of subjects experiencing a low-luminance visual acuity (LLVA) ≥15 Letter Loss from Baseline to M12
Proportion of subjects experiencing a low-luminance visual acuity (LLVA) ≥15 Letter Loss from Baseline to M12 as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) visual charts
Measured: Month 12
Rate of change of ellipsoid zone (EZ) area loss at Month 12
Rate of change of ellipsoid zone (EZ) area loss over Month 12 as assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT)
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start11 Aug 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, controlled, assessor masked study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 237 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocugen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohamed Genead, MD, Study chair, Ocugen., Inc.Jennifer Henrick, Study director, Ocugen., Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770828
- Sponsor's protocol ID
- OCU410-301
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Registrational Study To Assess The Efficacy, Safety, And Tolerability Of OCU410 For Geographic Atrophy Secondary To Dry Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07770828
- Acronym / sponsor ID
- OCU410-301
- Conditions
- Dry Age-related Macular Degeneration
- Keywords
- Geographical Atrophy, Dry Age Related
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- OcugenIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2031 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 3 multicenter, randomized, controlled, assessor blinded, adaptive study in which subjects will be randomized in a 2:1(OCU410: control) ratio to treatment arm or control arm
Detailed description
This study is a Phase 3 multicenter, randomized, controlled, assessor blinded, adaptive study in which subjects will be randomized in a 2:1(OCU410: control) ratio to either of the following arms:
Treatment arm (OCU410) study subjects will receive single subretinal injection of 200 µL, OCU410 in the study eye with the optimal dose (N=158)
Control arm (untreated) (N=79)
A total of 237 subjects will be enrolled in the study. Subjects who are enrolled in the untreated control group of the study will not receive any treatment. Subjects randomized to the treatment arm may receive a single subretinal injection of OCU410 in the study eye, provided they meet all treatment eligibility criteria. Subjects who are randomized to the control arm will not receive any intervention during the initial 52 weeks (12 Months) of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, randomized, controlled, assessor masked study
| Arm | Type | Receives |
|---|---|---|
| OCU410 | Experimental | Biological: OCU410OCU410 Single Sub Retinal Injection, 200 µL, 1×10^10 vg/eye |
| Untreated Control Arm | No intervention | –Control Arm (Untreated) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects 55 years of age or older at consent.
- BCVA of ≥25 ETDRS letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen Equivalent) and ≤80 ETDRS Letters (20/25 Snellen Equivalent) in the study eye.
- Fundus autofluorescence (FAF) imaging shows: a)Total GA area ≥2.5 and ≤ 17.5 mm2 (1 to 7 disk areas [DA], respectively); b)If GA is multifocal, at least one lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 3a. c)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 areas of peripapillary atrophy.
- Subjects with history of CNV diagnosis (inactive) in the fellow eye for ≥2 years prior to Screening; stable and treated CNV treatment prior to screening (stable and inactive); no active exudation at screening (confirmed by imaging at the discretion of the investigator)
- Subjects who had prior treatment with an approved drug for AMD, e.g. Izervay® (avacincaptad pegol) or Syfovre® (pegcetacoplan injection) can be included, after a washout period of at least 3 months in study eye from screening visit. Subjects can receive an approved drug for AMD in the fellow eye, if required.
Key exclusion criteria (5 listed)
- Previous treatment with a gene-therapy or cell therapy product.
- GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Plaquenil maculopathy. However, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e., paving stone degeneration).
- Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm, inability to fixate, uncontrolled glaucoma, advanced cataract, corneal abnormalities, medium haze, and other retinal pathologies.
- Any history or current evidence of exudative ("wet") AMD in the study eye including any evidence of retinal pigment epithelium rips, branch retinal artery or vein occlusion, corneal transplant, or evidence of neovascularization anywhere in the retina based on fluorescein angiogram. Subjects with active exudative CNV in the fellow eye will be exclude.
- Presence of double-layer sign on SD-OCT, suggestive of subclinical macular neovascularization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCU410Subretinal Injection | Biological | OCU410 |
Primary outcome
Rate of change (slope) of square root-transformed GA lesion area from baseline to Month 12
Time frame: Month 12
Rate of change (slope) of square root-transformed GA lesion area (√mm²/year) from baseline to Month 12 in treated eyes compared to control eyes as assessed by fundus autofluorescence (FAF) measurements
2 secondary outcomes
Proportion of subjects experiencing a low-luminance visual acuity (LLVA) ≥15 Letter Loss from Baseline to M12
Time frame: Month 12
Rate of change of ellipsoid zone (EZ) area loss at Month 12
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Genead, MD study chair
Ocugen., Inc.
Jennifer Henrick study director
Ocugen., Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OCU410 in people with Dry Age-related Macular Degeneration, run by Ocugen at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Umair Qazi, MD., MPH (12028170787, umair.qazi@ocugen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change (slope) of square root-transformed GA lesion area from baseline to Month 12 (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.