Trials / Terminated
TerminatedNCT04643886
A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Dry Age-related Macular Degeneration
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Gemini Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to investigate the safety, PK/PD, biomarker and early clinical effects of repeat GEM103 IVT injections.
Detailed description
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.
Conditions
- Dry Age-related Macular Degeneration
- Geographic Atrophy
- Macular Degeneration
- Retinal Disease
- Retinal Degeneration
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GEM103 | Biological |
Timeline
- Start date
- 2020-07-30
- Primary completion
- 2022-02-18
- Completion
- 2022-03-21
- First posted
- 2020-11-25
- Last updated
- 2022-09-23
Locations
29 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04643886. Inclusion in this directory is not an endorsement.