Safety and Tolerability of OCU-10-C-110 for Injection in Subjects With Neovascular Age-related Macular Degeneration

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

Study Overview

• Status: Active, not recruiting
• Conditions: Neovascular Age-related Macular Degeneration (nAMD)
• Intervention / Treatment: Drug: OCU-10-C-110 for Injection

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Raj K. Maturi, M.D., P.C.
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Research Institute of Texas
    • Willow Park, Texas, United States, 76087
      • Strategic Clinical Research Group LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. 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

Exclusion Criteria:

1. 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)

2. History or evidence of the following surgeries/procedures in the study eye:

   1. Submacular surgery
   2. Vitrectomy
   3. Retinal detachment or retinal tear
   4. Incisional glaucoma surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A - Dose 1	Drug: OCU-10-C-110 for Injection; OCU-10-C-110 for Injection in one of 3 doses
Experimental: Cohort A - Dose 2	Drug: OCU-10-C-110 for Injection; OCU-10-C-110 for Injection in one of 3 doses
Experimental: Cohort A - Dose 3	Drug: OCU-10-C-110 for Injection; OCU-10-C-110 for Injection in one of 3 doses
Experimental: Cohort B - Dose TBD	Drug: OCU-10-C-110 for Injection; OCU-10-C-110 for Injection in one of 3 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular safety - AE	Number of Adverse events	Cohort A - 8 weeks; Cohort B - 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic safety - AE	Number of Adverse events	Cohort A - 8 weeks; Cohort B - 12 weeks

Collaborators and Investigators

• Sponsor: Ocugenix Corporation
• Investigators: Study Director: Roger Goldberg, MD, Lexitas Pharma

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: neovascular age-related macular degeneration; intravitreal
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Wet Macular Degeneration; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: OCU-10-C-110-CS101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing plans for this Phase 1 study at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No