ACTIVE_NOT_RECRUITING

4D-150 in Patients With Diabetic Macular Edema

Conditions

Diabetic Macular Edema Diabetic Retinopathy Retinal gene therapy Intravitreal gene therapy DME SPECTRA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-08-09

Study Completion:2029-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05930561

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Julie Clark, MD

STUDY_DIRECTOR

4D Molecular Therapeutics

Study Locations (Sites)

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740

United States

Verum Research, LLC

Eugene, Oregon, 97401

United States

Erie Retina Research

Erie, Pennsylvania, 16507

United States

Austin Clinical Research

Austin, Texas, 78750

United States

Piedmont Eye Center

Lynchburg, Virginia, 24502

United States

Collaborators and Investigators

Sponsor: 4D Molecular Therapeutics

Julie Clark, MD, STUDY_DIRECTOR, 4D Molecular Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-09

Study Completion Date2029-02-28

Study Record Updates

Study Start Date2023-08-09

Study Completion Date2029-02-28

Terms related to this study

Keywords Provided by Researchers

Retinal gene therapy
Intravitreal gene therapy
DME
SPECTRA

Additional Relevant MeSH Terms

Diabetic Macular Edema
Diabetic Retinopathy