This study is designed to investigate the safety, PK/PD, biomarker and early clinical effects of repeat GEM103 IVT injections.
This is a Phase 2a, multi-center, open-label, multiple dose study in subjects with geographic atrophy (GA) secondary to dry Age-related Macular Degeneration (dry AMD) to investigate the safety, PK/PD, biomarker and early clinical effect of GEM103 repeat IVT injections. Subjects will undergo clinical and ophthalmic assessments for determination of inclusion in the study. Subjects who participated in the Phase 1 Study (GEM-CL-10301) as well as treatment naïve subjects that did not participate in the GEM-CL-10301 Study and who meet all eligibility criteria will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Biological
Safety of intravitreal (IVT) injections of GEM103, as measured by number of subjects with ocular adverse events.
Time frame: 18 months
To describe the clinical effect of GEM103 IVT injection, as the change from baseline in best corrected visual acuity (BCVA) scores as assessed by ETDRS scale.
Time frame: 6 months
To evaluate the total CFH levels in aqueous humor after GEM103 IVT injection, whenever possible.
Time frame: 6 months
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Gemini Clinical Trial Site
Phoenix, Arizona, United States
Gemini Clinical Trial Site
Bakersfield, California, United States
Gemini Clinical Trial Site
Beverly Hills, California, United States
Gemini Clinical Trial Site
Oxnard, California, United States
Gemini Clinical Trial Site
Poway, California, United States
Gemini Clinical Trial Site
Santa Barbara, California, United States
Gemini Clinical Trial Site
Santa Maria, California, United States
Gemini Clinical Trial Site
Golden, Colorado, United States
Gemini Clinical Trial Site
New London, Connecticut, United States
Gemini Clinical Trial Site
Palm Beach Gardens, Florida, United States
...and 19 more locations