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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 11 May 2025

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At a glance

  • Drugs 4D-150 (Primary) ; Aflibercept
  • Indications Diabetic macular oedema
  • Focus Registrational; Therapeutic Use
  • Acronyms SPECTRA
  • Sponsors 4D Molecular Therapeutics

Most Recent Events

  • 01 May 2025 According to a 4D Molecular Therapeutics media release, based on results form this trial to date, the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to 4D-150 for the treatment of diabetic macular edema (DME).
  • 28 Feb 2025 According to a 4D Molecular Therapeutics media release, interim data update form this trial expected at a scientific conference in Q3 2025.
  • 10 Jan 2025 According to a 4D Molecular Therapeutics media release, as per FDA feedback,company may proceed to Phase 3 (SPECTRA Part 2 no longer needed) and is aligned with key design elements of a Phase 3 clinical trial with approximately 300-400 patients total with a primary endpoint of BCVA noninferiority vs.on-label aflibercept 2mg (5 loading doses and Q8W), and revised supplemental injection criteria (less stringent compared to Part 1 SPECTRA, in line with prior successful Phase 3 DME clinical trials).

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