Overview

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

Status:
Not yet recruiting

Trial end date:
2025-05-01

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Ocugenix Corporation

Criteria

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