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A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)

Trial Profile

A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 Feb 2024

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At a glance

  • Drugs THR 149 (Primary) ; Aflibercept
  • Indications Diabetic macular oedema
  • Focus Proof of concept; Therapeutic Use
  • Acronyms KALAHARI
  • Sponsors Oxurion

Most Recent Events

  • 23 Nov 2023 Status changed from active, no longer recruiting to completed.
  • 20 Nov 2023 According to an Oxurion media release, continuation of trial followed recommendation from an Independent Data Monitoring Committee (IDMC) in Dec 2022 that it would not be futile for the KALAHARI trial to continue based on the outcome of a pre-specified futility analysis that included an evaluation of interim efficacy and safety data from 31 patients at Month 3 and followed encouraging data from the Part A dose-selection part of the KALAHARI trial.
  • 20 Nov 2023 Results presented in an Oxurion media release.

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