Aflibercept for Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

+1 other location

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Exegenesis Bio

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?In neovascular (wet) age-related macular degeneration (nAMD), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and leakage. This leakage affects the vision over time and can lead to severe blurriness or blinding. EXG102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision. Before EXG102-031 can be tested for its efficacy (if it makes vision better), it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with nAMD. This study is designed to fulfill the long-term safety monitoring of EXG102-031. Participants that enroll in this long-term follow-up study have been treated with EXG102-031 under the main study (EXG102-031-211).

Eligibility Criteria

This trial is for patients with wet age-related macular degeneration (nAMD) who have previously been treated with EXG102-031 under the main study. It's a long-term follow-up to monitor safety.

Inclusion Criteria

Must be willing and able to comply with all study procedures.

Are willing and able to sign the study written informed consent form

I was part of the EXG102-031-211 study and received EXG102-031 treatment.

Participant Groups

The intervention being studied is Aflibercept (2.0 mg), which aims to block abnormal blood vessel growth in the eye, potentially reducing vision leakage and damage in nAMD patients.

1Treatment groups

Experimental Treatment

Group I: All participants who completed the main study of EXG102-031Experimental Treatment1 Intervention

All subjects who enroll in this LTFU study have received the experimental treatment with EXG102-031 in the main study, however NO experimental therapy is being administered in this study. The intervention with Aflibercept IVT PRN in this study is NOT experimental.