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

Running, not enrolling · Phase 1

Conditions studied: Neovascular Age-related Macular Degeneration (nAMD)

In brief

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

Key facts

Study ID

NCT05904691

Run by

Ocugenix Corporation

People needed

24

Starts

2023-11-01

Expected to finish

2026-11-30

Last updated by the study team

2026-05-01

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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