4D-150 for Age-Related Macular Degeneration

(4FRONT-2 Trial)

Recruiting at 23 trial locations

Overseen By 4DMT Patient Advocacy

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: 4D Molecular Therapeutics

Must be taking: Anti-VEGF

Disqualifiers: Retinal detachment, Glaucoma, Uncontrolled blood pressure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Single injection

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Who Is on the Research Team?

Julie Tsai, MD

Principal Investigator

4D Molecular Therapeutics

Are You a Good Fit for This Trial?

Adults over 50 with macular neovascularization due to age-related macular degeneration (nAMD) can join. They must have a certain level of vision and retina thickness, and either be new to treatment or had up to four prior injections with documented improvement. Excluded are those with other causes for MNV, recent major illness/surgery, uncontrolled blood pressure, or history of heart/stroke events within the last 6 months.

Inclusion Criteria

My eye's central retina thickness is 500 microns or less.

BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit

I am 50 years old or older.

Exclusion Criteria

I have vision loss not caused by age-related macular degeneration.

My study eye has had a retinal detachment.

I have or had eye inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravitreal injection of 4D-150 or Aflibercept

Single injection

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• 4D-150

Trial Overview The trial is testing a single injection of an experimental drug called 4D-150 against EYLEA®, an approved treatment for nAMD. Participants will randomly receive one of these treatments in a double-masked setup where neither they nor the researchers know who gets which until after the results are collected.

How Is the Trial Designed?

Group I: 4D-150 IVT (3E10 vg/eye) Experimental Treatment 1 Intervention

Group II: Aflibercept (AFLB) 2 mg IVT Active Control 1 Intervention

Who Is Running the Clinical Trial?

4D Molecular Therapeutics

Lead Sponsor

Trials

9

Recruited

850+