This Phase 3 study is evaluating the safety and how well it works of 4D-150 versus aflibercept in participants with neovascular age-related macular degeneration (nAMD). Enrollment in the primary global cohort has been completed; Study centers in Japan remain open for enrollment for the Japan cohort.
Official registry: https://clinicaltrials.gov/study/NCT07064759 · 4D Molecular Therapeutics · enrollment listed as 480
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are 4D-150 IVT (3E10 vg/eye), or EYLEA® (aflibercept) Injection 2 mg (0.05mL). The registry lists allocation as randomized. This Phase 3 study is evaluating the safety and how well it works of 4D-150 versus aflibercept in participants with neovascular age-related macular degeneration (nAMD).
They plan to enroll about 480 people at 126 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Interventions: 4D-150 IVT (3E10 vg/eye), EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Primary outcome (registry wording): Mean change from baseline in Best Corrected Visual Acuity (BCVA) Early Treatment for Diabetic Retinopathy (ETDRS) letter score at Week 52
4DMT Patient Advocacy
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 66 sites outside the US on the same record
Background: \- Best Vitelliform Dystrophy (Best disease), Late-Onset Retinal Degeneration (L-ORD), and Age-Related Macular Degeneration (AMD) all affect the retina, the light sensing area at the back of the eye. Doctors cannot safely obtain retinal cells to study these diseases.
NCT01432847 · Official ClinicalTrials.gov record · National Eye Institute (NEI)
Background: \- To understand diseases of the retina and the eye, information is needed about people with and without such diseases. Researchers want to study these people and follow them over time.
NCT01496625 · Official ClinicalTrials.gov record · National Eye Institute (NEI)
This study will measure the long-term whether it is safe and how hard side effects are to live with of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomly assigned in WR42221.
NCT03683251 · Official ClinicalTrials.gov record · Hoffmann-La Roche
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary