A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Dry Age-related Macular Degeneration
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|ClinicalTrials.gov Identifier: NCT04643886|
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : November 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dry Age-related Macular Degeneration Geographic Atrophy Macular Degeneration Retinal Disease Retinal Degeneration||Drug: GEM103||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Multiple Dose Study in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Repeat Intravitreal Injections of GEM103|
|Actual Study Start Date :||July 30, 2020|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2022|
Experimental: Cohort with Genetic Profile A
Subjects will have Genetic Profile A.
Intervention: Biological: GEM103.
Experimental: Cohort with Genetic Profile B
Subjects will have Genetic Profile B.
Intervention: Biological: GEM103
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643886
|Contact: Gemini Therapeutics, Inc.||firstname.lastname@example.org|