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?

This trial tests a new treatment called 4D-150 for individuals with age-related macular degeneration (AMD), a condition that affects vision. The researchers aim to determine if 4D-150 can manage this condition more effectively than the existing treatment, aflibercept, an injection used for AMD. Participants should have an AMD diagnosis and either have never received certain eye injections or have had only a minimal number. This trial targets those who have shown some improvement with past treatments but still exhibit active signs of the disease. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot have glaucoma requiring more than 2 topical medications for control.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that 4D-150 is generally safe for patients. Earlier research found no serious side effects and no eye swelling, suggesting that 4D-150 is safe for use in the eye. This is promising for treating age-related macular degeneration. While encouraging, the current trial will provide more information about its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about 4D-150 for age-related macular degeneration because it uses a novel gene therapy approach. While most treatments like Aflibercept work by inhibiting VEGF proteins to slow vision loss, 4D-150 delivers genetic material directly into the eye to potentially provide a longer-lasting effect. This could mean fewer injections and more sustained results for patients, making it a promising alternative to current therapies.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

Research shows that 4D-150, which participants in this trial may receive, has promising results for treating age-related macular degeneration (AMD), especially the wet type. Studies have found that 4D-150 can help maintain clear and stable vision over time. It also reduces the need for additional injections, offering more convenience and comfort for patients. The treatment steadily releases a protein that reduces abnormal blood vessel growth in the eye, aiding in managing wet AMD symptoms. Overall, past research indicates that 4D-150 has been well-tolerated, with no significant eye inflammation reported. ^{3 6 7 8 9}

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+

Citations

1.

ir.4dmoleculartherapeutics.com

ir.4dmoleculartherapeutics.com/news-releases/news-release-details/4dmt-announces-positive-long-term-data-phase-12-prism-clinical

Release Details

4D-150 demonstrated consistent and durable benefit across all three patient cohorts as evidenced by maintenance of visual acuity, ...

2.

ir.4dmoleculartherapeutics.com

ir.4dmoleculartherapeutics.com/news-releases/news-release-details/4dmt-presents-positive-60-week-results-4d-150-spectra-clinical

4DMT Presents Positive 60-Week Results from 4D-150 ...

4D-150 continues to be well tolerated with no intraocular inflammation observed at any timepoint or dose level; 4D-150 demonstrated durable ...

3.

ophthalmologytimes.com

ophthalmologytimes.com/view/4dmt-releases-positive-interim-1-5--to-3-5-year-data-from-phase-1-2-prism-trial

4DMT releases positive interim 1.5- to 3.5-year data from ...

4D-150 demonstrated sustained anti-VEGF delivery, improving visual acuity and reducing supplemental injections in wet AMD patients over 1.5 to ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05197270

NCT05197270 | 4D-150 in Patients With Neovascular (Wet ...

This Phase 1/2 trial is a prospective, multicenter, Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD ...

5.

ir.4dmoleculartherapeutics.com

ir.4dmoleculartherapeutics.com/news-releases/news-release-details/4dmt-presents-positive-52-week-results-phase-2b-cohort-prism-wet

4DMT Presents Positive 52-Week Results from Phase 2b ...

4DMT Presents Positive 52-Week Results from Phase 2b Cohort of PRISM Wet AMD Study and Long-term Durability Data Supporting 4D-150 4FRONT Global ...

6.

4dmt.gcs-web.com

4dmt.gcs-web.com/news-releases/news-release-details/4dmt-announces-positive-long-term-data-phase-12-prism-clinical

4DMT Announces Positive Long-Term Data from Phase 1/2 ...

4D-150 continues to be well tolerated with no new safety ... The Company's lead indication for 4D-150 is wet age-related macular degeneration ...

7.

ir.4dmoleculartherapeutics.com

ir.4dmoleculartherapeutics.com/news-releases/news-release-details/4dmt-announces-positive-interim-data-4d-150-spectra-clinical

4DMT Announces Positive Interim Data from 4D-150 ...

Across all DME patients dosed to date, 4D-150 continues to be well tolerated with no intraocular inflammation observed at any timepoint or ...

8.

healio.com

healio.com/news/ophthalmology/20240820/video-safety-data-encouraging-for-4d150-in-patients-with-wet-amd

VIDEO: Safety data encouraging for 4D-150 in patients with ...

In this video, Donald J. D'Amico, MD, discusses data from the phase 1/2 PRISM trial of 4D-150 in patients with neovascular age-related ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06864988

Study Details | NCT06864988 | 4D-150 in Patients With ...

≥50 years of age at time of consent · MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield ...