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Neovascular Age-Related Macular Degeneration (nAMD)Phase 1NCT06817343

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

A Phase 1 study testing Aflibercept (2.0 mg) in people with Neovascular Age-Related Macular Degeneration (nAMD) and Neovascular (Wet) Age-related Macular Degeneration (AMD), run by Exegenesis Bio at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
What is being tested?
Aflibercept (2.0 mg)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
10 Sep 2024to Feb 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Must have been previously enrolled in the parent study (EXG102-031-211) and must have received subretinal EXG102-031 in the parent study;
  • Are willing and able to sign the study written informed consent form;
  • Must be willing and able to comply with all study procedures.
  • There are no exclusion Criteria in this study.

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Erie Retina Research

    Erie, Pennsylvania, 16507

  • Sierra Eye Associates

    Reno, Nevada, 89502

Other trials in United States

About this study

Official title: An Open-label, Long-term Follow-Up Study to Evaluate the Safety and Tolerability of Gene Therapy With EXG102-031 in Participants With Neovascular Age-related Macular Degeneration

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).

Read the detailed description

Age-related macular degeneration (AMD) is a major cause of blindness and visual impairment in older adults. The wet form of AMD, also called neovascular AMD (nAMD) usually causes faster vision loss than the dry form. The most common current treatments of nAMD are products that inhibit vascular endothelial growth factor (VEGF) (including ranibizumab (LUCENTIS®, Genentech) and aflibercept (EYLEA®, Regeneron) and are delivered by intravitreal injections at 4 to 16 week intervals and continued indefinitely. The Phase I, open-label, multiple-cohort, dose-escalation study designed to evaluate the safety and tolerability of EXG102-031 gene therapy in subjects with previously treated nAMD (EXG102-031-211). In the main study safety was assessed over 52 weeks after the administration of EXG102-031. This long-term follow-up study will assess safety for an additional 36 months for all participants enrolled in the main study. Participants will return to the clinic regularly for ocular assessments including assessment of whether supplemental therapy with aflibercept is needed.

Being tested
Aflibercept (2.0 mg)
Keywords
EXG102-031, wAMD
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aflibercept (2.0 mg)Biological

    PRN IVT Aflibercept

Study groups in NCT06817343
Study groupRoleWhat they receive
All participants who completed the main study of EXG102-031OtherAll 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.
Receives: Biological: Aflibercept (2.0 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 36

Secondary outcomes (1)

  1. Evaluation of potential efficacy by measuring change from baseline in best corrected visual acuity (BCVA) measured using the ETDRS method and average number of doses of aflibercept supplemental therapy through Month 36 (Year 4)

    Measured: Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2025
  2. Study start10 Sep 2024
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Participants from the main study, EXG102-031 (211), will rollover to this study and will be offered Aflibercept IVT PRN to control wAMD symptoms.
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06817343
Sponsor's protocol ID
EXG102-031-211-LTFU
Status last verified
Apr 2026
First submitted
30 Jan 2025
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Aflibercept (2.0 mg) in people with Neovascular Age-Related Macular Degeneration (nAMD) and Neovascular (Wet) Age-related Macular Degeneration (AMD), run by Exegenesis Bio at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06817343.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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