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

Launched by OCUGENIX CORPORATION · Jun 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called OCU-10-C-110 for people with a condition known as neovascular age-related macular degeneration (nAMD), which can cause vision problems due to abnormal blood vessel growth in the eye. The trial aims to assess the safety of this treatment by giving participants single and repeated doses of the medication in one eye and observing how well they tolerate it. The study is currently looking for volunteers who are 18 years or older and have an active eye condition linked to AMD.

To be eligible, participants must have had a specific type of eye issue confirmed by medical imaging within the last 10 weeks and must have received a prior treatment with a similar eye injection. Throughout the trial, participants will attend regular visits to monitor their health and the effects of the medication. It’s important for potential participants to be aware that certain health conditions or previous eye surgeries may prevent them from joining the study. This trial provides an opportunity to contribute to research that may help improve treatments for AMD in the future.

Gender

ALL

Eligibility 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