4D-150 in Patients With Diabetic Macular Edema

Phase 2

Recruiting

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.

Recruitment & Eligibility

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
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.

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
Annualized number of aflibercept injections in the study eye	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	104 weeks
Percentage of subjects with a ≥2 and ≥3-Step Diabetic Retinopathy Severity (DRS) improvement from baseline on the ETDRS-DRSS	104 weeks
Change from baseline in CST measured by spectral domain optical coherence tomography (SD-OCT)	104 weeks

Locations (15): Retina Vitreous Associates of Florida
🇺🇸
Saint Petersburg, Florida, United States
Retinal Research Institute LLC
🇺🇸
Phoenix, Arizona, United States
Retina Consultants of Southern Colorado
🇺🇸
Colorado Springs, Colorado, United States
National Ophthalmic Research Institute
🇺🇸
Fort Myers, Florida, United States
Retina Specialty Institute
🇺🇸
Pensacola, Florida, United States
Raj K Maturi MD PC
🇺🇸
Carmel, Indiana, United States
Cumberland Valley Retina Consultants
🇺🇸
Hagerstown, Maryland, United States
Sierra Eye Associates
🇺🇸
Reno, Nevada, United States
Vision Research Center Eye Associates of New Mexico
🇺🇸
Albuquerque, New Mexico, United States
Western Carolina Retinal Associates
🇺🇸
Asheville, North Carolina, 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