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4D-150 in Patients With Diabetic Macular Edema | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

4D-150 in Patients With Diabetic Macular Edema

A Phase 2 Randomized, Active-Controlled, Double-masked Trial of Intravitreal 4D-150 Gene Therapy in Adults With Diabetic Macular Edema (SPECTRA)

NCT05930561•4D Molecular Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Key Dates

Start Date

August 9, 2023

Primary Completion Date

February 28, 2029

Completion Date

February 28, 2029

Last Updated

September 22, 2025

Enrollment

ESTIMATED participants

Conditions

Diabetic Macular EdemaDiabetic Retinopathy

Interventions

4D-150 IVT

BIOLOGICAL

Aflibercept IVT

BIOLOGICAL

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449936

Diabetic Macular EdemaDME+1 more

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RECRUITINGPHASE3

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449923

Diabetic Macular EdemaDME+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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4D-150 in Patients With Diabetic Macular Edema

Inclusion Criteria

Exclusion Criteria

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

A Study of Avoralstat In Participants With Diabetic Macular Edema

Impact of the New Generation Anti-diabetic Drugs on Diabetic Retinopathy

Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)

Evaluation of K9 in Subjects With Diabetic Macular Edema (DME)