EXG102-031 for Wet Age-Related Macular Degeneration

Phase 1

Recruiting

Led By Arshad Khanani, MD

Research Sponsored by Exegenesis Bio

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 throughout 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a new drug is safe for people with wet AMD, to stop the abnormal blood vessel growth and leakage that can lead to severe vision loss.

Who is the study for?

This trial is for men and women over 50 with wet age-related macular degeneration (nAMD) who've had some response to previous treatments. They must have a certain level of vision clarity in the affected eye, which should be pseudophakic (after cataract surgery). Participants need to understand the study and consent to join. Those with severe scarring, recent eye surgeries, other major eye diseases, or untreated glaucoma can't join.

What is being tested?

EXG102-031 is being tested for safety in patients with nAMD. The drug aims to block abnormal blood vessel growth in the eye that causes vision loss by leaking fluid into the macula. This phase of testing will determine if it's safe before checking its effectiveness on improving vision.

What are the potential side effects?

Since EXG102-031 is early in testing, specific side effects aren't listed yet. Generally, such drugs may cause irritation at injection site, inflammation inside the eye, increased intraocular pressure or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout 52 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Evaluation of safety and tolerability

Secondary study objectives

Evaluation of potential efficacy

Evaluation of potential safety

Evaluation of supplementary therapy injections received

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EXG102-031Experimental Treatment1 Intervention

Each participant will receive a single subretinal injection of EXG102-031 in the study eye. Participants will be enrolled into one of four dosage groups sequentially, and the dose administered will be determined based on which study group the participant is enrolled into.

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