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
In Part A, subjects will receive a single intravitreal dose in a single eye of the drug product. Dose will be escalated in 3 successive cohorts, pending safety. In Part B, subjects will receive 3 treatments in a single eye of drug product at 4 week intervals of the maximally tolerated dose, with an additional 4 weeks of observation for safety. .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
OCU-10-C-110 for Injection in one of 3 doses
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
Ocular safety - AE
Number of Adverse events
Time frame: Cohort A - 8 weeks; Cohort B - 12 weeks
Systemic safety - AE
Number of Adverse events
Time frame: Cohort A - 8 weeks; Cohort B - 12 weeks
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