4FRONT-2
Research type
Research Study
Full title
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 (4FRONT-2)
IRAS ID
1012179
Contact name
Catherine Campbell
Contact email
Sponsor organisation
4D Molecular Therapeutics, Inc.
Research summary
This study will test an investigational gene therapy known as 4D-150 (“study drug”) to treat Neovascular age-related macular degeneration (nAMD) or wet AMD.
nAMD or wet AMD, is an eye disease in older adults. It happens when blood vessels grow in the back of your eye (called retina) impacting participants macula which is responsible for their central vision. This growth is not normal and is stimulated by a protein called vascular endothelial growth factor (VEGF). The blood vessels can leak causing a blind spot in the central vision. Wet AMD causes 90% of all AMD related blindness.
The current treatment for wet AMD is an anti-vascular endothelial growth factor (anti-VEGF) therapy. This type of drug inhibits the production of VEGF. Anti-VEGFs treatments, such as Eylea® (aflibercept) injection (hereinafter “Eylea®”) find these unhealthy VEGF molecules and block them. Most patients need injections every 4 or 8 weeks to maintain their vision or prevent vision loss. These repeated injections can be difficult for some patients and their caregivers.
The study drug delivers therapeutic genes to the retina by using a modified virus, called Adeno-Associated Virus (AAV).
4D-150 is an AAV that has been modified to carry two genes to treat wet AMD in the eye. One gene helps the eye make an Eylea® molecule, and the other makes a molecule called miRNA. miRNA tells retinal cells to make less VEGF-C, which is believed to cause wet AMD.
By helping cells in the eye produce both their own Eylea® and miRNA against VEGF-C (molecules that help reduce the proteins in the eye that cause abnormal blood vessels to grow), 4D-150 hopes to reduce the the need for repeated injections of Eylea® or other similar treatments available on the market for wet AMD. The purpose of this study is to test how safe and effective the study drug is in reducing injections of anti-VEGFs in participants with wet AMD.
Eligible participants will be in the study for about 24 months (2 years).REC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0568
Date of REC Opinion
24 Sep 2025
REC opinion
Further Information Favourable Opinion