4D-150 in Patients With Diabetic Macular Edema

Description

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

Conditions

Diabetic Macular Edema, Diabetic Retinopathy

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Study Overview

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Study Details

Study overview

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

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

4D-150 in Patients With Diabetic Macular Edema

Condition
Diabetic Macular Edema
Intervention / Treatment

-

Contacts and Locations

Phoenix

Retinal Research Institute LLC, Phoenix, Arizona, United States, 85053

Colorado Springs

Retina Consultants of Southern Colorado, Colorado Springs, Colorado, United States, 80909

Fort Myers

National Ophthalmic Research Institute, Fort Myers, Florida, United States, 33912

Pensacola

Retina Specialty Institute, Pensacola, Florida, United States, 32503

Saint Petersburg

Retina Vitreous Associates of Florida, Saint Petersburg, Florida, United States, 33711

Carmel

Raj K Maturi MD PC, Carmel, Indiana, United States, 46290

Hagerstown

Cumberland Valley Retina Consultants, Hagerstown, Maryland, United States, 21740

Reno

Sierra Eye Associates, Reno, Nevada, United States, 89502

Albuquerque

Vision Research Center Eye Associates of New Mexico, Albuquerque, New Mexico, United States, 87109

Asheville

Western Carolina Retinal Associates, Asheville, North Carolina, United States, 28803

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

4D Molecular Therapeutics,

Schonmei Lee, MD, STUDY_DIRECTOR, 4D Molecular Therapeutics

Study Record Dates

2028-07-01