Neovascular Age-related Macular Degeneration (nAMD)Phase 1NCT05904691
Safety and Tolerability of OCU-10-C-110 for Injection in Subjects With Neovascular Age-related Macular Degeneration
A Phase 1 study testing OCU-10-C-110 for Injection in people with Neovascular Age-related Macular Degeneration (nAMD), run by Ocugenix Corporation at 3 sites in United States.
Trial summary
Multi-center, open-label, two-part safety assessment following administration of single ascending doses and repeat administration of the HTD of OCU-10-C-110 for Injection in the study eye of participants with nAMD Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration (nAMD)
- What is being tested?
- OCU-10-C-110 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2023to 30 Nov 2026
- Phase
- Phase 1
- 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
- Angiographically documented active choroidal neovascular (CNV) lesion (i.e., leakage on fluorescein angiography or subretinal, intraretinal, or sub-retinal pigment epithelium [sub-RPE] fluid on spectral domain optical coherence tomography [SD-OCT]) secondary to age-related macular degeneration (AMD), within the previous 10 weeks
- Subjects must have received, 7 to 14 days prior to the Baseline Visit, an intravitreal injection in the study eye of an anti-vascular endothelial growth factor (VEGF) ocular therapeutic approved for use in the United States
Who cannot join
- History or current evidence of a medical condition (systemic or ophthalmic disease, metabolic dysfunction, physical examination finding or clinical laboratory finding) that may, in the opinion of the investigator, preclude the safe administration of the study medication, adherence to the scheduled study visits, or safe participation in the study or affect the results of the study (e.g., unstable or progressive cardiovascular, cerebral vascular, pulmonary, Parkinson's, liver or renal disease, depression, cancer, or dementia)
- History or evidence of the following surgeries/procedures in the study eye:
- Submacular surgery
- Vitrectomy
- Retinal detachment or retinal tear
- Incisional glaucoma surgery
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Raj K. Maturi, M.D., P.C.
Carmel, Indiana, 46290
Strategic Clinical Research Group LLC
Willow Park, Texas, 76087
About this study
Official title: Safety and Tolerability of Single Ascending Doses and Multiple Repeat Doses of OCU-10-C-110 for Injection in Study Participants With Neovascular Age-related Macular Degeneration (nAMD)
Multi-center, open-label, two-part safety assessment following administration of single ascending doses and repeat administration of the HTD of OCU-10-C-110 for Injection in the study eye of participants with nAMD
Read the detailed description
In Part A, subjects will receive a single intravitreal dose in a single eye of the drug product. Dose will be escalated in 3 successive cohorts, pending safety. In Part B, subjects will receive 3 treatments in a single eye of drug product at 4 week intervals of the maximally tolerated dose, with an additional 4 weeks of observation for safety. .
- Being tested
- OCU-10-C-110 for Injection
- Keywords
- neovascular age-related macular degeneration; intravitreal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCU-10-C-110 for InjectionDrug
OCU-10-C-110 for Injection in one of 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Dose 1 | Experimental | Not described Receives: Drug: OCU-10-C-110 for Injection |
| Cohort A - Dose 2 | Experimental | Not described Receives: Drug: OCU-10-C-110 for Injection |
| Cohort A - Dose 3 | Experimental | Not described Receives: Drug: OCU-10-C-110 for Injection |
| Cohort B - Dose TBD | Experimental | Not described Receives: Drug: OCU-10-C-110 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular safety - AE
Number of Adverse events
Measured: Cohort A - 8 weeks; Cohort B - 12 weeks
Secondary outcomes (1)
Systemic safety - AE
Number of Adverse events
Measured: Cohort A - 8 weeks; Cohort B - 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Nov 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular Degeneration (nAMD)Studies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Multi-center, open-label, two-part safety assessment
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocugenix Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Goldberg, MD, Study director, Lexitas Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904691
- Sponsor's protocol ID
- OCU-10-C-110-CS101
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing plans for this Phase 1 study at this time.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Single Ascending Doses and Multiple Repeat Doses of OCU-10-C-110 for Injection in Study Participants With Neovascular Age-related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT05904691
- Acronym / sponsor ID
- OCU-10-C-110-CS101
- Keywords
- neovascular age-related macular degeneration; intravitreal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ocugenix CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 15 Jun 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.
Multi-center, open-label, two-part safety assessment following administration of single ascending doses and repeat administration of the HTD of OCU-10-C-110 for Injection in the study eye of participants with nAMD
Detailed description
In Part A, subjects will receive a single intravitreal dose in a single eye of the drug product. Dose will be escalated in 3 successive cohorts, pending safety. In Part B, subjects will receive 3 treatments in a single eye of drug product at 4 week intervals of the maximally tolerated dose, with an additional 4 weeks of observation for safety. .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Multi-center, open-label, two-part safety assessment
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Dose 1 | Experimental | Drug: OCU-10-C-110 for Injection |
| Cohort A - Dose 2 | Experimental | Drug: OCU-10-C-110 for Injection |
| Cohort A - Dose 3 | Experimental | Drug: OCU-10-C-110 for Injection |
| Cohort B - Dose TBD | Experimental | Drug: OCU-10-C-110 for Injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Angiographically documented active choroidal neovascular (CNV) lesion (i.e., leakage on fluorescein angiography or subretinal, intraretinal, or sub-retinal pigment epithelium [sub-RPE] fluid on spectral domain optical coherence tomography [SD-OCT]) secondary to age-related macular degeneration (AMD), within the previous 10 weeks
- Subjects must have received, 7 to 14 days prior to the Baseline Visit, an intravitreal injection in the study eye of an anti-vascular endothelial growth factor (VEGF) ocular therapeutic approved for use in the United States
Key exclusion criteria (6 listed)
- History or current evidence of a medical condition (systemic or ophthalmic disease, metabolic dysfunction, physical examination finding or clinical laboratory finding) that may, in the opinion of the investigator, preclude the safe administration of the study medication, adherence to the scheduled study visits, or safe participation in the study or affect the results of the study (e.g., unstable or progressive cardiovascular, cerebral vascular, pulmonary, Parkinson's, liver or renal disease, depression, cancer, or dementia)
- History or evidence of the following surgeries/procedures in the study eye:
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 |
|---|---|---|
| OCU-10-C-110 for InjectionOCU-10-C-110 for Injection in one of 3 doses | Drug | Cohort A - Dose 1, Cohort A - Dose 2, Cohort A - Dose 3, Cohort B - Dose TBD |
Primary outcome
Ocular safety - AE
Time frame: Cohort A - 8 weeks; Cohort B - 12 weeks
Number of Adverse events
1 secondary outcome
Systemic safety - AE
Time frame: Cohort A - 8 weeks; Cohort B - 12 weeks
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 1 May 2026.
- Individual participant dataSharing planned: No. No sharing plans for this Phase 1 study at this time.
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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. This study is not recruiting at the moment.
Roger Goldberg, MD study director
Lexitas Pharma
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OCU-10-C-110 for Injection in people with Neovascular Age-related Macular Degeneration (nAMD), run by Ocugenix Corporation 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 2 inclusion and 6 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 1 May 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 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.
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?
Ocular safety - AE (time frame: Cohort A - 8 weeks; Cohort B - 12 weeks). 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 1 May 2026.