Geographic AtrophyPhase 1/2ArMaDaNCT06018558
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
A Phase 1/2 study testing OCU410 in people with Geographic Atrophy, run by Ocugen at 12 sites in United States.
Trial summary
This is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (AMD). This is a multicenter study, which will be conducted in two phases and will enroll up to a total of 60 subjects. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy
- 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
- 60 participants
- Where
- 12 sitesUnited States
- Study dates
- 23 Feb 2023to 3 Feb 2030
- Phase
- Phase 1/2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 50 years of age or older.
- BCVA of approximately 21 letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen equivalent).
- Fundus autofluorescence (FAF) imaging shows:
- Total GA area ≥2.0 and ≤20.5 mm2 (1 and 8 disk areas [DA], respectively)
- If GA is multifocal, at least one focal lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 3.a
- 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
- Presence of any pattern of hyper-autofluorescence in the junctional zone of GA
- Subjects who had prior treatment with an approved drug for AMD, e.g. Izerway® (Avacincaptad pegol) or Syfovre® (Pegcetacoplan injection) can be included, after a washout period of at least 3 months in study eye. 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., pavingstone 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 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
B) Retina Consultants of Texas
Bellaire, Texas, 77401
Miidwest Eye Institute
Carmel, Indiana, 46290
Mid Atlantic Retina
Cherry Hill, New Jersey, 08034
Advanced Research, LLC
Coral Springs, Florida, 33067
A) Retina Foundation of the Southwest
Dallas, Texas, 75231
Duke Eye Center
Durham, North Carolina, 27710
Mississippi Retina Associates
Jackson, Mississippi, 39202
Gundersen Health System
La Crosse, Wisconsin, 54601
Valley retina Institute
McAllen, Texas, 78503
Associated Retina Consultants
Phoenix, Arizona, 85020
The University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
The Retina Institute
St Louis, Missouri, 63128
About this study
Official title: A Phase 1/2 Study to Assess the Safety And Efficacy Of OCU410 For Geographic Atrophy Secondary To Dry Age-Related Macular Degeneration
This is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (AMD).
This is a multicenter study, which will be conducted in two phases and will enroll up to a total of 60 subjects.
Read the detailed description
Name of Sponsor/Company:
Ocugen, Inc. 11 Great Valley Parkway Malvern, PA 19355
Name of Investigational Product: OCU410
Name of Active Ingredient:
Adeno-associated viral vector 5 human RORA (AAV5-hRORA) Protocol Number: OCU410-101 Phase: 1/2 Country: US
Title of Study:
A Phase 1/2 Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration.
Study Center(s): Approximately 14 clinical study centers in the US.
Background:
Age-related Macular Degeneration (AMD) is an ocular disease where macular degenerative occurs. AMD manifests in two forms, Dry (nonexudative, atrophic) AMD and Wet (exudative, neovascular) AMD. Geographic atrophy (GA) is an advanced stage of dry AMD that affects nearly 1 million people in the US and 5 million people worldwide, with its prevalence increasing exponentially with age. It leads to progressive and irreversible loss of visual function due to the growth of atrophic lesions that destroy the retinal cells responsible for vision.
OCU410 Product Information:
Ocugen, Inc., has developed a proprietary modifier gene therapy platform, OCU410, as the second agent in a novel class of NHR-based gene modifier therapy for patients with dry AMD. The proposed indication for OCU410 (AAV5-hRORA) is for the treatment of GA secondary to dry AMD. The drug product is a sterile ophthalmic suspension for subretinal injection. OCU410 therapy regulates gene pathways contributing to GA by restoring homeostasis in the eye and thereby serving as a therapeutic candidate for dry AMD. The modifier gene therapy platform is a new way of addressing a genetic disease arising through a multitude of genetic mutations in various genes but leading to the same end result (phenotype) of a diseased condition.
This study will be conducted in two phases enrolling up to 60 subjects. Treated subjects will receive a single subretinal injection of OCU410 in the study eye.
Phase 1 is a multicenter, open-label, dose-ranging/dose-escalating study with a 3+3 design enrolling 9 subjects.
Phase 2 is a dose-expansion phase of the study, where up to 51 subjects will be randomized in 1:1:1 ratio to either two OCU410 dose groups (n=17 per group) or to an untreated control group (n=17).
.
- Conditions
- Geographic Atrophy
- Being tested
- OCU410
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCU410Genetic
Subretinal administration of OCU410
| Study group | Role | What they receive |
|---|---|---|
| Phase1 Dose Escalation- Low Dose (2.5×10E10 vg/mL): | Experimental | Low Dose (2.5×10E10 vg/mL): Subjects will receive a subretinal injection of OCU410 in the low dose concentration. Receives: Genetic: OCU410 |
| Phase1 Dose Escalation- Medium Dose (5×10E10 vg/mL): | Experimental | Medium Dose (5×10E10 vg/mL): Subjects will receive a subretinal injection of OCU410 in the medium dose concentration. Receives: Genetic: OCU410 |
| Phase1 Dose Escalation- High Dose (1.5×10E11 vg/mL): | Experimental | High Dose (1.5×10E11 vg/mL): Subjects will receive a subretinal injection in the high dose concentration. Receives: Genetic: OCU410 |
| Phase 2 Dose Expansion: Maximum tolerated dose (MTD) from Phase 1-Randomized Arm | Experimental | Maximum tolerated dose (MTD) from Phase 1: Subjects will receive a subretinal injection in the MTD concentration. Receives: Genetic: OCU410 |
| Phase 2 Dose Expansion: Lower Dose from Phase 1-Randomized Arm | Experimental | Subjects will receive a subretinal injection of OCU410 in a Lower Dose concentration. Receives: Genetic: OCU410 |
| Control Arm | No intervention | No Intervention Control Arm: Subject will not receive any active study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events))
The primary endpoint is safety, determined by the number of ocular and non-ocular Study Drug-related adverse events (SDAE), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Measured: 12 months (Screening to 12 months post OCU410 administration)
Change in anatomy of ocular structures using Slit Lamp Biomicroscopy
We will use Slit-lamp Biomicroscopy to visualize the anatomy of ocular structures before and after sub-retinal injections and follow-up visits.
Measured: 12 months (Screening to 12 months post OCU410 administration)
Change in anatomy of ocular structures using Indirect ophthalmoscopy
We will use Indirect ophthalmoscopy to visualize the anatomy of ocular structures before and after sub-retinal injections and follow-up visits.
Measured: 12 months (Screening to 12 months post OCU410 administration)
Change from baseline in BCVA (Best Corrected Visual Acuity)
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision.
Measured: 12 months (Screening to 12 months post OCU410 administration)
Change in Low Luminance Visual Acuity
Measured by letter score. A higher score represents better vision
Measured: 12 months (Screening to 12 months post OCU410 administration)
Change in the Intraocular Pressure (mmHg)
Measured by applanation or rebound tonometry with confirmation with Goldmann tonometer if IOP is outside normal range (8-21mmHg).
Measured: 12 months (Screening to 12 months post OCU410 administration)
Secondary outcomes (3)
Humoral and cellular immune response
Blood samples will be collected for the assessment. The secondary safety endpoints include change from baseline in Humoral and cellular immune response in response to OCU410 administration
Measured: 12 months (Screening to 12 months post OCU410 administration)
Shedding of viral vector
Blood samples will be collected for the assessment to determine AAV vector shedding in systemic circulation after OCU410 administration
Measured: 12 months (Screening to 12 months post OCU410 administration)
Laboratory parameters including serum chemistry and hematology
Blood samples will be collected for the assessment to determine a change from baseline after OCU410 administration.
Measured: 12 months (Screening to 12 months post OCU410 administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start23 Feb 2023
- Primary completion3 Feb 2026
- Study completion3 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Study will be conducted in 2 phases: Phase 1 will be 3+3 design will be used for sequential dose-escalation cohorts in which subjects will receive a single subretinal injection of OCU410 in the study eye. Phase 2 is a dose-expansion phase of the study, where up to 51 subjects will be randomized in 1:1:1 ratio to either two OCU410 dose groups (n=17 per group) or to an untreated control group (n=17).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocugen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Henrick, RN, MS, Study director, Ocugen., Inc.Mohamed Genead, MD, Study chair, Ocugen., Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018558
- Sponsor's protocol ID
- OCU410-101
- Acronym
- ArMaDa
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be made available to qualified researchers on reasonable request to the sponsor (Ocugen, Inc.), after publication of the study results, subject to a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study to Assess the Safety And Efficacy Of OCU410 For Geographic Atrophy Secondary To Dry Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT06018558
- Acronym / sponsor ID
- ArMaDa / OCU410-101
- Conditions
- Geographic Atrophy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- OcugenIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 3 Feb 2026 (actual)
- Study completion
- 3 Feb 2030 (estimated)
- First posted
- 30 Aug 2023 (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 is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (AMD).
This is a multicenter study, which will be conducted in two phases and will enroll up to a total of 60 subjects.
Detailed description
Name of Sponsor/Company:
Ocugen, Inc. 11 Great Valley Parkway Malvern, PA 19355
Name of Investigational Product: OCU410
Name of Active Ingredient:
Adeno-associated viral vector 5 human RORA (AAV5-hRORA) Protocol Number: OCU410-101 Phase: 1/2 Country: US
Title of Study:
A Phase 1/2 Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration.
Study Center(s): Approximately 14 clinical study centers in the US.
Background:
Age-related Macular Degeneration (AMD) is an ocular disease where macular degenerative occurs. AMD manifests in two forms, Dry (nonexudative, atrophic) AMD and Wet (exudative, neovascular) AMD. Geographic atrophy (GA) is an advanced stage of dry AMD that affects nearly 1 million people in the US and 5 million people worldwide, with its prevalence increasing exponentially with age. It leads to progressive and irreversible loss of visual function due to the growth of atrophic lesions that destroy the retinal cells responsible for vision.
OCU410 Product Information:
Ocugen, Inc., has developed a proprietary modifier gene therapy platform, OCU410, as the second agent in a novel class of NHR-based gene modifier therapy for patients with dry AMD. The proposed indication for OCU410 (AAV5-hRORA) is for the treatment of GA secondary to dry AMD. The drug product is a sterile ophthalmic suspension for subretinal injection. OCU410 therapy regulates gene pathways contributing to GA by restoring homeostasis in the eye and thereby serving as a therapeutic candidate for dry AMD. The modifier gene therapy platform is a new way of addressing a genetic disease arising through a multitude of genetic mutations in various genes but leading to the same end result (phenotype) of a diseased condition.
This study will be conducted in two phases enrolling up to 60 subjects. Treated subjects will receive a single subretinal injection of OCU410 in the study eye.
Phase 1 is a multicenter, open-label, dose-ranging/dose-escalating study with a 3+3 design enrolling 9 subjects.
Phase 2 is a dose-expansion phase of the study, where up to 51 subjects will be randomized in 1:1:1 ratio to either two OCU410 dose groups (n=17 per group) or to an untreated control group (n=17).
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Study will be conducted in 2 phases: Phase 1 will be 3+3 design will be used for sequential dose-escalation cohorts in which subjects will receive a single subretinal injection of OCU410 in the study eye. Phase 2 is a dose-expansion phase of the study, where up to 51 subjects will be randomized in 1:1:1 ratio to either two OCU410 dose groups (n=17 per group) or to an untreated control group (n=17).
| Arm | Type | Receives |
|---|---|---|
| Phase1 Dose Escalation- Low Dose (2.5×10E10 vg/mL): | Experimental | Genetic: OCU410Low Dose (2.5×10E10 vg/mL): Subjects will receive a subretinal injection of OCU410 in the low dose concentration. |
| Phase1 Dose Escalation- Medium Dose (5×10E10 vg/mL): | Experimental | Genetic: OCU410Medium Dose (5×10E10 vg/mL): Subjects will receive a subretinal injection of OCU410 in the medium dose concentration. |
| Phase1 Dose Escalation- High Dose (1.5×10E11 vg/mL): | Experimental | Genetic: OCU410High Dose (1.5×10E11 vg/mL): Subjects will receive a subretinal injection in the high dose concentration. |
| Phase 2 Dose Expansion: Maximum tolerated dose (MTD) from Phase 1-Randomized Arm | Experimental | Genetic: OCU410Maximum tolerated dose (MTD) from Phase 1: Subjects will receive a subretinal injection in the MTD concentration. |
| Phase 2 Dose Expansion: Lower Dose from Phase 1-Randomized Arm | Experimental | Genetic: OCU410Subjects will receive a subretinal injection of OCU410 in a Lower Dose concentration. |
| Control Arm | No intervention | –No Intervention Control Arm: Subject will not receive any active study intervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects 50 years of age or older.
- BCVA of approximately 21 letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen equivalent).
- Fundus autofluorescence (FAF) imaging shows:
- Subjects who had prior treatment with an approved drug for AMD, e.g. Izerway® (Avacincaptad pegol) or Syfovre® (Pegcetacoplan injection) can be included, after a washout period of at least 3 months in study eye. Subjects can receive an approved drug for AMD in the fellow eye, if required.
Key exclusion criteria (4 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., pavingstone 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 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.
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 administration of OCU410 | Genetic | Phase 2 Dose Expansion: Lower Dose from Phase 1-Randomized Arm, Phase 2 Dose Expansion: Maximum tolerated dose (MTD) from Phase 1-Randomized Arm, Phase1 Dose Escalation- High Dose (1.5×10E11 vg/mL):, Phase1 Dose Escalation- Low Dose (2.5×10E10 vg/mL):, Phase1 Dose Escalation- Medium Dose (5×10E10 vg/mL): |
Primary outcome
Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events))
Time frame: 12 months (Screening to 12 months post OCU410 administration)
The primary endpoint is safety, determined by the number of ocular and non-ocular Study Drug-related adverse events (SDAE), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Change in anatomy of ocular structures using Slit Lamp Biomicroscopy
Time frame: 12 months (Screening to 12 months post OCU410 administration)
We will use Slit-lamp Biomicroscopy to visualize the anatomy of ocular structures before and after sub-retinal injections and follow-up visits.
Change in anatomy of ocular structures using Indirect ophthalmoscopy
Time frame: 12 months (Screening to 12 months post OCU410 administration)
We will use Indirect ophthalmoscopy to visualize the anatomy of ocular structures before and after sub-retinal injections and follow-up visits.
Change from baseline in BCVA (Best Corrected Visual Acuity)
Time frame: 12 months (Screening to 12 months post OCU410 administration)
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision.
Change in Low Luminance Visual Acuity
Time frame: 12 months (Screening to 12 months post OCU410 administration)
Measured by letter score. A higher score represents better vision
Change in the Intraocular Pressure (mmHg)
Time frame: 12 months (Screening to 12 months post OCU410 administration)
Measured by applanation or rebound tonometry with confirmation with Goldmann tonometer if IOP is outside normal range (8-21mmHg).
3 secondary outcomes
Humoral and cellular immune response
Time frame: 12 months (Screening to 12 months post OCU410 administration)
Shedding of viral vector
Time frame: 12 months (Screening to 12 months post OCU410 administration)
Laboratory parameters including serum chemistry and hematology
Time frame: 12 months (Screening to 12 months post OCU410 administration)
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 30 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be made available to qualified researchers on reasonable request to the sponsor (Ocugen, Inc.), after publication of the study results, subject to a data use agreement.
Related trials for Geographic Atrophy
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, Macular Degeneration
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. This study is not recruiting at the moment.
Jennifer Henrick, RN, MS study director
Ocugen., Inc.
Mohamed Genead, MD study chair
Ocugen., Inc
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OCU410 in people with Geographic Atrophy, run by Ocugen at 12 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 8 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events)) (time frame: 12 months (Screening to 12 months post OCU410 administration)). The study lists 6 primary outcomes in all. 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 30 Oct 2026.