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Active, Not Recruiting

NCT Number: NCT05930561

4D-150 in Patients With Diabetic Macular Edema

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Macular Edema Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emanuelli Research and Development Center, Arecibo, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

4D-150 IVT

Biological

4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept.

Aflibercept IVT

Biological

Commercially available Active Comparator

Other names: Eylea

Primary outcomes

  1. Incidence and severity of TEAEs and SAEs, including clinically significant changes in safety parameters (Part 1)

    Time frame: 60 months

  2. Annualized number of aflibercept injections in the study eye (Part 2)

    Time frame: 52 weeks

Secondary outcomes

  1. Mean cumulative number of aflibercept injections over time

    Time frame: 52 weeks

  2. Change from baseline in BCVA as assessed using the ETDRS Visual Acuity Chart at Weeks 52 and 104

    Time frame: 104 weeks

  3. Change from baseline in CST measured by spectral domain optical coherence tomography (SD-OCT) at Weeks 104

    Time frame: 104 weeks

Other outcomes

  1. Incidence and severity of treatment-emergent adverse events and serious adverse events, including clinically significant changes in safety parameters

    Time frame: 104 weeks

  2. Development of anti-drug antibodies to capsid protein (4D-R100) and the transgene product (aflibercept) and change in antibody titers in subjects receiving 4D-150

    Time frame: 104 weeks

  3. Change in levels of aflibercept protein in aqueous humor and serum overtime

    Time frame: 104 weeks

Sponsors and collaborators

Lead sponsor

4D Molecular Therapeutics

Industry

Registry information

Official study title

A Phase 2 Randomized, Active-Controlled, Double-masked Trial of Intravitreal 4D-150 Gene Therapy in Adults With Diabetic Macular Edema (SPECTRA)

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jul 5, 2023
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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