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

Phase 1

Recruiting

• Conditions: Neovascular Age-related Macular Degeneration (nAMD)
• Interventions: Drug: OCU-10-C-110 for Injection

• Registration Number: NCT05904691
• Lead Sponsor: Ocugenix Corporation

Brief 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

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 Timeline

• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Study Start: 2023-11-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort A - Dose 1	OCU-10-C-110 for Injection	-
Cohort A - Dose 2	OCU-10-C-110 for Injection	-
Cohort A - Dose 3	OCU-10-C-110 for Injection	-
Cohort B - Dose TBD	OCU-10-C-110 for Injection	-

Primary Outcome Measures

Name	Time	Method
Ocular safety - AE	Cohort A - 8 weeks; Cohort B - 12 weeks	Number of Adverse events

Secondary Outcome Measures

Name	Time	Method
Systemic safety - AE	Cohort A - 8 weeks; Cohort B - 12 weeks	Number of Adverse events

Trial Locations

Locations (3)

Retina Research Institute of Texas; 🇺🇸 Abilene, Texas, United States

Strategic Clinical Research Group LLC; 🇺🇸 Willow Park, Texas, United States

Raj K. Maturi, M.D., P.C.; 🇺🇸 Carmel, Indiana, United States