Phase 3 Study of Intravitreal 4D-150 in Adults With Diabetic Macular Edema (DME) (4D-150-C005) (4SIGHT)

4D Molecular Therapeutics (4DMT)

Status and phase: Enrolling; Phase 3

Conditions: Diabetic Macular Edema (DME)

Treatments: Biological: EYELEA ® (aflibercept) Injection 2 mg (0.05mL); Biological: 4D-150 IVT (3x10^10 vg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07867080

4SIGHT (Other Identifier)

4D-150-C005 (Other Identifier)

Details and patient eligibility

About

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Safety, Efficacy, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)

Enrollment: 514 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

5.2 Inclusion Criteria

Individuals eligible to participate in the trial must meet the following inclusion criteria:

General Inclusion Criteria

1. Signed informed consent before any protocol-specified assessment is performed
2. Ability and willingness to comply with the protocol-specified procedures (including IVT injection) and visits, in the Investigator's judgment
3. ≥18 years of age at time of signing informed consent
4. Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
5. WOCBP must agree to use highly effective contraception from the time of informed consent, through duration of trial participation
6. Agree to use a barrier method (e.g., condom) during intercourse for 3 months after Day 1 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period Ocular Inclusion Criteria
7. Macular thickening secondary to DME involving the center of the fovea (confirmed by the Reading Center) in the study eye
8. Study eye amenable to IVT injection identified
9. Presence of intraretinal fluid and/or subretinal fluid secondary to DME
10. Decreased visual acuity attributable primarily to DME, as determined by the Investigator
11. Demonstrated clinical response to aflibercept and functional stability in the study eye

Exclusion Criteria: Individuals who meet any of the following exclusion criteria will not be eligible to participate:

Ocular Condition

1. Macular conditions other than DME

2. History or presence of moderate Proliferative Diabetic Retinopathy or worse

3. History of retinal detachment in the study eye

4. History or presence of active inflammation or infection in either eye

5. History or presence of low Intraocular Pressure

6. Uncontrolled glaucoma or intraocular hypertension

   Ocular Treatments/Interventions:

7. Any prior concomitant treatment for DME

8. History of prior significant ocular surgery or treatment

9. Any prior investigational drug, agent, device, or gene therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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514 participants in 2 patient groups

4D-150 IVT (3x10^10 vg/eye)

Experimental group

Treatment:

Biological: 4D-150 IVT (3x10^10 vg)

Active Comparator (AFLB) 2mg IVT

Active Comparator group

Treatment:

Biological: EYELEA ® (aflibercept) Injection 2 mg (0.05mL)