4D-150 for Age-Related Macular Degeneration
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called 4D-150 for individuals with wet age-related macular degeneration (AMD), a condition that affects vision. The study will explore different doses of 4D-150 and compare them to a standard treatment, Aflibercept (an anti-VEGF injection), which already manages AMD. Individuals diagnosed with AMD and currently receiving anti-VEGF treatment might be suitable candidates for this trial. The goal is to assess the safety and effectiveness of 4D-150 and determine if it can be a better option for managing wet AMD. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants the chance to contribute to groundbreaking advancements in AMD management.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that you continue receiving anti-VEGF treatment in the study eye.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatment 4D-150 is generally safe for people. In earlier studies, 4D-150 did not cause swelling inside the eye. Researchers tested the treatment at different doses, and no serious eye issues were reported. These results suggest that 4D-150 is safe for use in people, with only minor side effects observed so far.12345
Why are researchers excited about this trial's treatments?
Most treatments for age-related macular degeneration (AMD) involve regular injections of medications like aflibercept, which target and inhibit proteins that lead to blood vessel growth in the eye. However, 4D-150 is unique because it is a gene therapy delivered via a single intravitreal (IVT) injection that aims to provide long-lasting effects by using a new method to potentially reduce the frequency of treatments. This innovative approach could alleviate the burden of frequent doctor visits and improve patient compliance, making it a promising option for those dealing with AMD. Researchers are excited about 4D-150 because it represents a shift from managing symptoms to potentially altering the disease process itself.
What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?
Research has shown that 4D-150, one of the treatments in this trial, may help treat age-related macular degeneration (AMD). In one study, patients' vision improved, allowing them to read an average of 8.4 more letters on an eye chart over 32 weeks. Another study found that patients experienced better vision and less fluid in their eyes, which is promising for managing wet AMD. This treatment is designed to deliver a protein called anti-VEGF, which helps reduce abnormal blood vessel growth over an extended period. This could mean fewer injections are needed. Overall, 4D-150 appears safe, with no serious eye inflammation reported. Participants in this trial may receive 4D-150 at various dose levels or Aflibercept as a control treatment.12678
Who Is on the Research Team?
Patricia Isabell Manalastas, MD
Principal Investigator
4D Molecular Therapeutics
Are You a Good Fit for This Trial?
This trial is for adults over 50 with wet Age-Related Macular Degeneration (AMD) who have been treated with at least 6 anti-VEGF injections in the past year and shown improvement. They should have a certain level of vision, not worse than ~20/320. Those with central fovea damage, history of uveitis, or previous specific eye treatments are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive a single dose of 4D-150 by intravitreal injection at assigned dose levels
Dose Expansion
Participants receive a single dose of 4D-150 by intravitreal injection at assigned dose levels
Steroid Optimization
Participants receive a single dose of 4D-150 by intravitreal injection with steroid optimization
Population Extension
Participants receive a single dose of 4D-150 by intravitreal injection at assigned dose levels
Follow-up
Participants undergo monthly assessments for safety and efficacy outcomes
Long-term Follow-up
Participants are monitored for long-term safety and duration of clinical activity of 4D-150 gene therapy
What Are the Treatments Tested in This Trial?
Interventions
- 4D-150 IVT
- Aflibercept IVT
Find a Clinic Near You
Who Is Running the Clinical Trial?
4D Molecular Therapeutics
Lead Sponsor