Active — Not RecruitingPhase 1

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

United States24 participantsStarted 2023-11-01

Plain-language 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

Who can participate

Age range50 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Ocular safety - AE

Timeframe: Cohort A - 8 weeks; Cohort B - 12 weeks

Trial details

NCT IDNCT05904691

SponsorOcugenix Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-30

View on ClinicalTrials.gov More Neovascular Age-related Macular Degeneration (nAMD) trials