4D-150 for Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

+23 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: 4D Molecular Therapeutics

Must be taking: Anti-VEGF

Disqualifiers: Uveitis, Photodynamic therapy, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment

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.

What data supports the effectiveness of the drug 4D-150 IVT for age-related macular degeneration?

Research shows that similar drugs like aflibercept (Eylea) and ziv-aflibercept (Zaltrap) have been effective in improving vision and reducing fluid in the eyes of patients with age-related macular degeneration, suggesting potential effectiveness for 4D-150 IVT as well.

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Is 4D-150 safe for humans?

Research on similar treatments like ziv-aflibercept and aflibercept (Eylea) shows they are generally safe for eye conditions like age-related macular degeneration and diabetic macular edema, with no adverse events reported in short-term studies.

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How is the drug 4D-150 IVT different from other treatments for age-related macular degeneration?

4D-150 IVT is unique because it combines aflibercept, a drug that helps reduce abnormal blood vessel growth in the eye, with a novel approach that may offer improved outcomes for patients who do not respond well to other treatments like bevacizumab and ranibizumab.

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Eligibility Criteria

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

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.

Trial Timeline

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

Participant Groups

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.

Group I: 4D-150 Steroid Optimization Experimental Treatment 1 Intervention

4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.

Group II: 4D-150 Population Extension Dose 3 Experimental Treatment 1 Intervention

4D-150 will be administered at the assigned dose

Group III: 4D-150 Population Extension Dose 2 Experimental Treatment 1 Intervention

4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.

Group IV: 4D-150 Population Extension Dose 1 Experimental Treatment 1 Intervention

4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.

Group V: 4D-150 Dose Expansion Dose 2 Experimental Treatment 1 Intervention

4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.

Group VI: 4D-150 Dose Expansion Dose 1 Experimental Treatment 1 Intervention

4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.

Group VII: 4D-150 Dose Escalation up to 4 dose levels Experimental Treatment 1 Intervention

4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.

Group VIII: 4D-150 Dose Expansion Control Active Control 1 Intervention

Aflibercept at a fixed regimen will be administered.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Western Carolina Retinal Associates Asheville, NC

Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser Center Boston, MA

Retinal Specialty Institute Pensacola, FL

Retina Vitreous Associates of Florida Tampa, FL

More Trial Locations

Who Is Running the Clinical Trial?

4D Molecular Therapeutics Lead Sponsor

References

1. Greece pubmed.ncbi.nlm.nih.gov

Intravitreal aflibercept (A-IVI) for the treatment of neovascular age-related macular degeneration (nv-AMD): one year experience. [2019] To report the anatomical and functional results of intravitreal injections of aflibercept (Eylea) (A-IVI) for the treatment of naïve eyes with neovascular age-related macular degeneration (nv-AMD).

2. United States pubmed.ncbi.nlm.nih.gov

Intravitreal injection of ziv-aflibercept in patient with refractory age-related macular degeneration. [2015] The results of a patient with exudative age-related macular degeneration who received an intravitreal injection of ziv-aflibercept (Zaltrap; Sanofi-Aventis, Paris, France) in the right eye are described. A complete ocular examination as well as color fundus photography, optical coherence tomography, fluorescein angiography, microperimetry, full-field electroretinography, and multifocal electroretinography were performed and repeated 1 month later. The patient experienced subjective and objective improvement of visual acuity with a decrease in intraretinal and subretinal fluid. Microperimetric improvement also occurred. Electroretinographic changes were noted from baseline to the 30-day follow-up. No adverse events were observed at any time point. Ziv-aflibercept demonstrated short-term safety and efficacy after intravitreal administration for neovascular macular degeneration.

3. England pubmed.ncbi.nlm.nih.gov

One-year outcome of intravitreal ziv-aflibercept therapy for non-responsive neovascular age-related macular degeneration. [2018] To evaluate 12-month outcome of intravitreal ziv-aflibercept (IVZ) therapy in eyes with neovascular age-related macular degeneration (nAMD) that are non-responsive to bevacizumab and ranibizumab.

4. United States pubmed.ncbi.nlm.nih.gov

SHORT-TERM SAFETY PROFILE OF INTRAVITREAL ZIV-AFLIBERCEPT. [2022] To evaluate the safety of intravitreal ziv-aflibercept (Zaltrap) in the treatment choroidal neovascularization secondary to age-related macular degeneration.

5. United States pubmed.ncbi.nlm.nih.gov

Intravitreal Ziv-Aflibercept for Diabetic Macular Edema: 48-Week Outcomes. [2019] To study the safety and efficacy of intravitreal injections of ziv-aflibercept (IVI-ZA) (Zaltrap; Sanofi-Aventis and Regeneron Pharmaceuticals, Tarrytown, NY) during a period of 48 weeks in patients with diabetic macular edema (DME).

6. England pubmed.ncbi.nlm.nih.gov

Prospective exploratory study to assess the safety and efficacy of aflibercept in cystoid macular oedema associated with retinitis pigmentosa. [2021] To report the safety and efficacy of intravitreal aflibercept (Eylea) (ivA) for retinitis pigmentosa-associated cystoid macular oedema (RP-CMO) at 12 months via mean central macular thickness (CMT) and reported adverse events.