4D-150 for Diabetic Macular Edema

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: 4D Molecular Therapeutics

Must be taking: Aflibercept

Must not be taking: Anti-VEGF, Corticosteroids

Disqualifiers: Macular edema, Gene therapy, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Phase 2 randomized, active-controlled, double-masked, dose-ranging trial in adults with Diabetic Macular Edema (DME).

Will I have to stop taking my current medications?

The trial requires that you stop taking systemic anti-VEGF treatments and systemic corticosteroids or other immunosuppressive medications before participating. If you are on these medications, you will need to stop them for a certain period before joining the trial.

What data supports the effectiveness of the drug 4D-150 IVT for treating diabetic macular edema?

Research shows that aflibercept (Eylea), a component of 4D-150 IVT, significantly improves vision in patients with diabetic macular edema compared to other treatments. Studies have demonstrated its effectiveness in improving visual acuity and reducing eye swelling over time.

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Is 4D-150 safe for humans?

Studies on similar treatments like aflibercept (Eylea) and ziv-aflibercept (Zaltrap) for conditions such as diabetic macular edema and retinitis pigmentosa have shown that these treatments are generally safe, with some patients experiencing mild side effects like eye discomfort or increased eye pressure.

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What makes the drug 4D-150 IVT unique for treating diabetic macular edema?

4D-150 IVT is unique because it combines aflibercept, a well-known anti-vascular endothelial growth factor (anti-VEGF) drug, with a novel approach that may enhance its effectiveness in treating diabetic macular edema. This combination could potentially offer improved outcomes compared to standard treatments like macular laser photocoagulation or other anti-VEGF drugs.

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Eligibility Criteria

Adults over 18 with Diabetic Macular Edema (DME) diagnosed within the last two years, who've shown improvement after an aflibercept eye injection. Participants must have certain levels of vision in the affected eye and be able to undergo further injections. Those with other causes for macular edema or on recent anti-VEGF/corticosteroid treatments can't join.

Inclusion Criteria

My eye condition improved after receiving an aflibercept injection.

Provide written informed consent

My eyes are healthy enough for detailed exams and tests.

Exclusion Criteria

My eye condition may need surgery within the next 2 years.

My macular edema is not due to diabetic macular edema.

I haven't taken any experimental treatments in the last 3 months or 5 half-lives, whichever is longer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Confirmation

Participants receive a single dose IVT injection of 4D-150 at the assigned dose level on Day 1

1 day

1 visit (in-person)

Dose Expansion

Participants receive a single dose IVT injection of 4D-150 at the assigned dose level on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Participant Groups

The trial is testing a new treatment called 4D-150 compared to Aflibercept, both administered through an injection into the eye (IVT). It's designed to see which is better at improving vision for people with DME. Patients are randomly assigned to receive one of these treatments and won't know which they're getting.

Group I: 4D-150 Part 2 Dose Expansion Dose Level 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 II: 4D-150 Part 2 Dose Expansion Dose Level 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 III: 4D-150 Part 1 Dose Confirmation Dose Level 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 Part 1 Dose Confirmation Dose Level 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 Part 2 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:

Retina Vitreous Associates of Florida Saint Petersburg, FL

Retinal Research Institute LLC Phoenix, AZ

Retina Vitreous Associates of FL Saint Petersburg, FL

Sierra Eye Associates Reno, NV

More Trial Locations

Who Is Running the Clinical Trial?

4D Molecular Therapeutics Lead Sponsor

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Aflibercept: A Review of Its Use in Diabetic Macular Oedema. [2022] Aflibercept (Eylea(®)) is an anti-vascular endothelial growth factor agent indicated for intravitreal use in the treatment of diabetic macular oedema. In patients with diabetic macular oedema, significantly greater improvements from baseline to week 52 in visual acuity were seen with intravitreal aflibercept versus macular laser photocoagulation in the phase III VISTA-DME and VIVID-DME trials, and versus intravitreal bevacizumab or ranibizumab in those with worse visual acuity at baseline (i.e. Early Treatment Diabetic Retinopathy Study letter score of

2. Japan pubmed.ncbi.nlm.nih.gov

Treat-and-extend therapy with aflibercept for diabetic macular edema: a prospective clinical trial. [2021] To investigate the efficacy and safety of a treat-and-extend (T&E) regimen using aflibercept (Eylea) for diabetic macular edema (DME).

3. 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).

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

Intravitreal aflibercept for diabetic macular oedema: Moorfields' real-world 12-month visual acuity and anatomical outcomes. [2022] Label="OBJECTIVES" NlmCategory="OBJECTIVE">To assess structural and functional outcomes of treatment with intravitreal aflibercept (Eylea®) for diabetic macular oedema in treatment-naive patients.

5. 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.

6. 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).

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

Safety and Efficacy of Ziv-Aflibercept in the Treatment of Refractory Diabetic Macular Edema. [2022] To evaluate the safety and efficacy of ziv-aflibercept (Zaltrap; Sanofi-Aventis, Bridgewater, NJ/Regeneron Pharmaceuticals, Tarrytown, NY) in the treatment of refractory diabetic macular edema (DME).

8. Germany pubmed.ncbi.nlm.nih.gov

Real-world outcomes following 12 months of intravitreal aflibercept monotherapy in patients with diabetic macular edema in France: results from the APOLLON study. [2020] To report the effectiveness of intravitreal aflibercept (IVT-AFL) treatment for diabetic macular edema (DME) in French clinical practice.