4D-150 in Patients With Diabetic Macular Edema

4D Molecular Therapeutics (4DMT)

Status and phase: Enrolling; Phase 2

Conditions: Diabetic Macular Edema; Diabetic Retinopathy

Treatments: Biological: Aflibercept IVT; Biological: 4D-150 IVT

Study type: Interventional

Funder types: Industry

Identifiers

NCT05930561

4D-150-C002

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

72 participants in 5 patient groups

4D-150 Part 1 Dose Confirmation Dose Level 1

Experimental group

Description:

4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.

Treatment:

Biological: 4D-150 IVT

4D-150 Part 1 Dose Confirmation Dose Level 2

Experimental group

Description:

4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.

Treatment:

Biological: 4D-150 IVT

4D-150 Part 2 Dose Expansion Dose Level 1

Experimental group

Description:

4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.

Treatment:

Biological: 4D-150 IVT

4D-150 Part 2 Dose Expansion Dose Level 2

Experimental group

Description:

4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.

Treatment:

Biological: 4D-150 IVT

4D-150 Part 2 Dose Expansion Control

Active Comparator group

Description:

Aflibercept at a fixed regimen will be administered.

Treatment:

Biological: Aflibercept IVT