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

Phase 2

Waitlist Available

Research Sponsored by Gemini Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 48

Summary

This trial is testing an eye injection called GEM103, given with usual treatment, in patients with a severe form of age-related eye disease. It aims to see if the new injection is safe and tolerable.

Eligible Conditions

Retinal Degeneration
Age-Related Macular Degeneration
Macular Degeneration
Retinal Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change From Baseline in Minnesota Low-vision Reading (MNRead) Test at Week 48

Number of Participants With Abnormal Ophthalmic Examination Findings

Number of Participants With Non-ocular TEAEs

+3 more

Secondary study objectives

Change From Baseline in Total Complement Factor H (CFH) Concentration in Aqueous Humor

Diabetic Retinopathy

Mean Change From Baseline in Macular Atrophy (MA) Assessed by Fundus Autofluorescence (FAF)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SoC + GEM103Experimental Treatment2 Interventions

Participants 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.

Group II: SoC + ShamPlacebo Group2 Interventions

Participants 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GEM103

2019

Completed Phase 1

~20

Aflibercept

2016

Completed Phase 4

~2550