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4D-150 in Patients With Diabetic Macular Edema

NCT05930561

Active Not RecruitingPhase 2

Sponsor: 4D Molecular Therapeutics

Conditions: Diabetic Macular Edema, Diabetic Retinopathy

Interventions: 4D-150 IVT, Aflibercept IVT

Countries: United States, Puerto Rico

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (6)

Hagerstown, Maryland, United States
Eugene, Oregon, United States
Erie, Pennsylvania, United States
Austin, Texas, United States
Lynchburg, Virginia, United States
Arecibo, Puerto Rico, Puerto Rico