A Long-term Follow up Study of EXG102-031 in Patients With wAMD (Everest LTFU)

Part of paid clinical trials in Reno, Nevada.

Sponsor
Exegenesis Bio
Study ID
NCT06817343
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Neovascular (Wet) Age-related Macular Degeneration (AMD)
  • Neovascular Age-Related Macular Degeneration (nAMD)

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Sep 10, 2024
Status verified
Apr 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: All participants who completed the main study of EXG102-031
    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.

Primary Outcome Measure

Evaluation of long-term safety by measuring frequency, type, and intensity of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs) through Month 36 (Year 4) post EXG102-031 administration. [ Time Frame: Month 36 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Sierra Eye AssociatesRenoNevada89502-
Erie Retina ResearchEriePennsylvania16507-

Find similar trials in Reno, NV

By research site
Sierra Eye Associates· Reno, NVErie Retina Research· Erie, PA

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