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
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.