A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Gemini Therapeutics, Inc.
- Study ID
- NCT04684394
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Macular Degeneration
- Neovascular Age-related Macular Degeneration
- Retinal Degeneration
- Retinal Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- GEM103 — BIOLOGICALGEM103 500 mcg/50 mcL intravitreal injection
- Aflibercept — DRUGAflibercept 2 mg/50 mcL (SOC) intravitreal injection Sham intravitreal injection
- Sham — DRUGSham intravitreal injection
Study Details
This study is designed to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.
Key Dates
- Start date
- Dec 29, 2020
- Status verified
- Mar 2022
- Primary completion
- Jan 10, 2022
- Completion
- Feb 18, 2022
Study Design
- Enrollment
- 50 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SoC + GEM103Participants were administered SoC therapy defined as aflibercept (2 milligram \[mg\]/50 microliter \[mcL\]) first, followed by GEM103 (500 microgram \[mcg\]/50mcL) 15 minutes later. Administration occurred every other month (EOM) for a total of 6 doses during the 12-month study period.
- Sham Comparator: SoC + ShamParticipants were administered SoC therapy defined as aflibercept (2mg/50mcL) first, followed by the Sham injection 15 minutes later. Administration occurred EOM for a total of 6 doses during the 12-month study period.
Primary Outcome Measure
Number of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Week 48 ]
Locations (23)
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