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The trial is taking place at:
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Retina Specialty Institute | Pensacola, FL

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4D-150 in Patients With Diabetic Macular Edema

4

4D Molecular Therapeutics (4DMT)

Status and phase

Enrolling
Phase 2

Conditions

Diabetic Macular Edema
Diabetic Retinopathy

Treatments

Biological: 4D-150 IVT
Biological: Aflibercept 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

Trial contacts and locations

15

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Central trial contact

4DMT Patient Advocacy

Data sourced from clinicaltrials.gov

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