Aflibercept for Age-Related Macular Degeneration
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to ensure the long-term safety of a treatment called EXG102-031 (also known as Aflibercept) for individuals with neovascular (wet) age-related macular degeneration (nAMD). In nAMD, abnormal blood vessels grow and leak in the eye, causing blurry vision. EXG102-031 is designed to prevent this vessel growth and leakage. Participants who completed a previous study with EXG102-031 and wish to join this follow-up must have been part of the original study and be willing to adhere to the trial's procedures. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that aflibercept is safe for treating neovascular age-related macular degeneration (nAMD). The FDA has approved it for this use. Studies have found that most patients tolerate aflibercept well. The most common side effects are mild, such as eye pain or redness, while serious side effects are rare. This indicates that aflibercept has a strong safety record for people with nAMD.12345
Why are researchers excited about this trial?
Aflibercept is unique because it targets vascular endothelial growth factor (VEGF), which plays a key role in the abnormal blood vessel growth and leakage that lead to vision loss in age-related macular degeneration (AMD). Unlike other treatments that may require more frequent dosing, aflibercept is designed for longer intervals between injections, potentially offering more convenience for patients. Researchers are excited about aflibercept because it not only inhibits VEGF but also another growth factor involved in the disease process, potentially offering a more comprehensive approach to managing AMD.
What is the effectiveness track record for Aflibercept in treating age-related macular degeneration?
Research has shown that aflibercept effectively treats wet age-related macular degeneration (nAMD), a condition where abnormal blood vessels impair vision. Studies such as VIEW 1 and VIEW 2 demonstrated that aflibercept helps manage this condition by reducing fluid build-up and improving vision clarity. It blocks a protein called VEGF, which causes these abnormal vessels to grow. Some research suggests that higher doses of aflibercept may offer additional benefits. Overall, evidence supports aflibercept's ability to improve vision in people with nAMD.12567
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Main Study Treatment
Participants received EXG102-031 gene therapy and were monitored for safety and tolerability over 52 weeks
Long-term Follow-up
Participants are monitored for safety and tolerability of EXG102-031 for an additional 36 months, with regular ocular assessments and potential supplemental therapy with aflibercept
What Are the Treatments Tested in This Trial?
Interventions
- Aflibercept
Find a Clinic Near You
Who Is Running the Clinical Trial?
Exegenesis Bio
Lead Sponsor