4D-150 for Age-Related Macular Degeneration
What You Need to Know Before You Apply
What is the purpose of this trial?
Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment.Substudies will evaluate the safety and tolerability of 4D-150 contralateral eye dosing and characterize vector shedding.
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 4D-150 safe for humans?
How is the drug 4D-150 IVT different from other treatments for age-related macular degeneration?
What data supports the effectiveness of the drug 4D-150 IVT for age-related macular degeneration?
Who Is on the Research Team?
Jennifer Lee, 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