NCT04684394

A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration

A Multicenter, Multiple-Dose Study in Neovascular Age-related Macular Degeneration (nAMD) to Evaluate the Safety, Tolerability, Pharmacodynamics, Immunogenicity, and Clinical Effect of Repeat Intravitreal (IVT) Injections of GEM103 as an Adjunct to Standard of Care Aflibercept Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Gemini Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.

Detailed description

This is a Phase 2a, multi-center, multiple dose study in subjects with Neovascular Age-related Macular Degeneration (nAMD) to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care. Subjects will undergo clinical and ophthalmic assessments for determination of inclusion in the study and who meet all eligibility criteria will be enrolled.

Conditions

• Neovascular Age-related Macular Degeneration
• Retinal Disease
• Retinal Degeneration
• Macular Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	GEM103	GEM103 500 mcg/50 mcL intravitreal injection
DRUG	Aflibercept	Aflibercept 2 mg/50 mcL (SOC) intravitreal injection Sham intravitreal injection
DRUG	Sham	Sham intravitreal injection

Timeline

• Start date: 2020-12-29
• Primary completion: 2022-01-10
• Completion: 2022-02-18
• First posted: 2020-12-24
• Last updated: 2022-10-31
• Results posted: 2022-10-31

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study