Safety and Tolerability of OCU-10-C-110 for Injection in Subjects With Neovascular Age-related Macular Degeneration
Neovascular Age-related Macular Degeneration (nAMD)
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration (nAMD) focused on measuring neovascular age-related macular degeneration; intravitreal
Eligibility Criteria
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
Sites / Locations
- Strategic Clinical Research Group LLC
- Retina Research Institute of Texas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Cohort A - Dose 1
Cohort A - Dose 2
Cohort A - Dose 3
Cohort B - Dose TBD