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Compensation: Varies

Number of Visits: 28

215 Participants Needed

4D-150 for Age-Related Macular Degeneration

Recruiting at 20 trial locations

Overseen ByFuad Makkouk, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: 4D Molecular Therapeutics

Must be taking: Anti-VEGF

Disqualifiers: Uveitis, Photodynamic therapy, others

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

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.¹ ² ³ ⁴ ⁵

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.¹ ² ⁶ ⁷ ⁸

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

I am 50 years old or older.

I am being treated with anti-VEGF for my eye and it's working.

BCVA ETDRS Snellen equivalent for dose escalation between ~20/32 and ~20/320, or for dose expansion and population extension between ~20/25 and~20/200, for steroid optimization between ~20/25 and ~20/640

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Exclusion Criteria

I have had photodynamic therapy or retinal laser treatment in my study eye.

I have a condition that stops my vision from getting better in one eye.

I do not have eye conditions that would affect my participation in a study.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive a single dose of 4D-150 by intravitreal injection at assigned dose levels

1 day

1 visit (in-person)

Dose Expansion

Participants receive a single dose of 4D-150 by intravitreal injection at assigned dose levels

1 day

1 visit (in-person)

Steroid Optimization

Participants receive a single dose of 4D-150 by intravitreal injection with steroid optimization

1 day

1 visit (in-person)

Population Extension

Participants receive a single dose of 4D-150 by intravitreal injection at assigned dose levels

1 day

1 visit (in-person)

Follow-up

Participants undergo monthly assessments for safety and efficacy outcomes

24 months

24 visits (in-person)

Long-term Follow-up

Participants are monitored for long-term safety and duration of clinical activity of 4D-150 gene therapy

60 months

What Are the Treatments Tested in This Trial?

Interventions

4D-150 IVT
Aflibercept IVT

Trial Overview

The study tests two intravitreal treatments: Aflibercept (an existing drug) and an experimental drug called 4D-150 for wet AMD. It's a Phase 1/2 trial that starts by finding safe doses and then compares the drugs' effects in a controlled setup where participants don't know which treatment they're getting.

How Is the Trial Designed?

Treatment groups

Experimental Treatment

Active Control

Group I: 4D-150 Vector Shedding DoseExperimental Treatment1 Intervention