Conditions: Age-related Macular Degeneration
Keywords: First in human Safety Tolerability Serum PK Intravitreal (IVT) Age-related macular degeneration AMD Geographic Atrophy Choroidal neovascularization
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and serum pharmacokinetics of CLG561 in subjects with advanced age-related macular degeneration (AMD).

Detailed description:
Subjects were divided into 5 cohorts, with the subjects in each cohort being administered a single IVT dose of CLG561 in 1 of 5 concentration levels A-E, where A=lowest and E=highest. All subjects received active CLG561. Progress from one cohort to the next was time-lagged to allow for safety review. Dosing was also time-lagged within each cohort. Only one eye (designated as the study eye) was dosed per subject. Post-dose safety assessments and ocular examination occurred immediately after the IVT injection and continued throughout the outpatient visits at pre-determined timepoints. Collection of post-injection blood samples began after the IVT injection at pre-determined timepoints. Subjects were followed for up to 84 days.

Arms:
arm 1: Single 50 μL intravitreal injection of CLG561, Dose Level A arm 2: Single 50 μL intravitreal injection of CLG561, Dose Level B arm 3: Single 50 μL intravitreal injection of CLG561, Dose Level C arm 4: Single 50 μL intravitreal injection of CLG561, Dose Level D arm 5: Single 100 μL intravitreal injection of CLG561, Dose Level E

Interventions: intervention 1: CLG561
Intervention descriptions: intervention 1: Administered by intravitreal injection, Day 1

Protocol document: