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

Last updated: March 18, 2025
Sponsor: Ocugenix Corporation
Overall Status: Active - Recruiting

Phase

1

Condition

Geographic Atrophy

Macular Degeneration

Treatment

OCU-10-C-110 for Injection

Clinical Study ID

NCT05904691
OCU-10-C-110-CS101
  • Ages > 50
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Angiographically documented active choroidal neovascular (CNV) lesion (i.e., leakageon fluorescein angiography or subretinal, intraretinal, or sub-retinal pigmentepithelium [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, anintravitreal injection in the study eye of an anti-vascular endothelial growthfactor (VEGF) ocular therapeutic approved for use in the United States

Exclusion

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 ofthe study medication, adherence to the scheduled study visits, or safe participationin the study or affect the results of the study (e.g., unstable or progressivecardiovascular, 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:

  3. Submacular surgery

  4. Vitrectomy

  5. Retinal detachment or retinal tear

  6. Incisional glaucoma surgery

Study Design

Total Participants: 19
Treatment Group(s): 1
Primary Treatment: OCU-10-C-110 for Injection
Phase: 1
Study Start date:
November 01, 2023
Estimated Completion Date:
November 30, 2026

Study 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. .

Connect with a study center

  • Raj K. Maturi, M.D., P.C.

    Carmel, Indiana 46290
    United States

    Active - Recruiting

  • Retina Research Institute of Texas

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Strategic Clinical Research Group LLC

    Abilene, Texas 76087
    United States

    Site Not Available

  • Strategic Clinical Research Group LLC

    Willow Park, Texas 76087
    United States

    Active - Recruiting

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