4D-150 in Patients With Diabetic Macular Edema

Phase 2

Active, not recruiting

• Conditions: Diabetic Retinopathy; Diabetic Macular Edema
• Interventions: Biological: 4D-150 IVT; Biological: Aflibercept IVT

• Registration Number: NCT05930561
• Lead Sponsor: 4D Molecular Therapeutics

Brief Summary

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

Detailed Description

This Phase 2 trial is a prospective, multicenter, randomized, active-controlled, double-masked dose-ranging trial to evaluate the safety and efficacy of 4D-150 in adults with DME. The trial will be conducted in two parts: Dose Confirmation and Dose Expansion.

Study Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-07-05
• Study Start: 2023-08-09
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-17
• Last Update Posted: 2025-09-22
• Primary Completion: 2029-02-28
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• ≥18 years of age
• Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea; diagnosis of DME must be within 2 years of Screening
• CST ≥ 350 μm (Spectralis SD-OCT) in the study eye at Screening, confirmed by the independent reading center
• Demonstrate clinical response to on-study aflibercept injection in the study eye.
• Decreased visual acuity attributable primarily to DME
• BCVA in the study eye between 25 and 83 ETDRS letters, inclusive (~20/320 and 20/25, respectively) at Screening
• Study eye amenable to IVT injection
• Sufficient clear ocular media, pupil dilation and fixation in the study eye to permit adequate imaging; ability to perform tests of visual and retinal function and structure; and ability to comply with other protocol-specified procedures
• Provide written informed consent

Exclusion Criteria

• Macular edema in the study eye considered to be secondary to a cause other than DME
• Systemic anti-VEGF treatment (e.g. sunitinib, bevacizumab, pazopanib) within 6 months, or anticipated need for systemic anti-VEGF therapy during study participation
• Systemic corticosteroids (oral, intravenous, intramuscular, intra-articular) or other immunosuppressive medications within 3 months
• Received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months (or at least 5 half-lives, whichever is longer) prior to 4D-150 administration (Day 1)
• Prior gene therapy (ocular or non-ocular) and/or ocular stem cell therapy in either eye
• Any concurrent ocular condition in the study eye that is likely to require surgical intervention (e.g. cataract surgery) during the 2 year (104 week) study duration

Note: Other inclusion/exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4D-150 Part 2 Dose Expansion Dose Level 1	4D-150 IVT	4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 Part 1 Dose Confirmation Dose Level 1	4D-150 IVT	4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 Part 1 Dose Confirmation Dose Level 2	4D-150 IVT	4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 Part 2 Dose Expansion Dose Level 2	4D-150 IVT	4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 Part 2 Dose Expansion Control	Aflibercept IVT	Aflibercept at a fixed regimen will be administered.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of TEAEs and SAEs, including clinically significant changes in safety parameters (Part 1)	60 months
Annualized number of aflibercept injections in the study eye (Part 2)	52 weeks

Secondary Outcome Measures

Name	Time	Method
Mean cumulative number of aflibercept injections over time	52 weeks
Change from baseline in BCVA as assessed using the ETDRS Visual Acuity Chart at Weeks 52 and 104	104 weeks
Change from baseline in CST measured by spectral domain optical coherence tomography (SD-OCT) at Weeks 104	104 weeks

Trial Locations

Locations (6)

Cumberland Valley Retina Consultants; 🇺🇸 Hagerstown, Maryland, United States

Verum Research, LLC; 🇺🇸 Eugene, Oregon, United States

Erie Retina Research; 🇺🇸 Erie, Pennsylvania, United States

Austin Clinical Research; 🇺🇸 Austin, Texas, United States

Piedmont Eye Center; 🇺🇸 Lynchburg, Virginia, United States

Emanuelli Research and Development Center; 🇵🇷 Arecibo, Puerto Rico