A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Alkahest, Inc.
Updated on 27 September 2021
Investigator
Synergy East
Primary Contact
Borsod-Aba j-Zempl n Megyei K rh z s Egyetemi Oktat K rh z (Borsod-Aba j-Zempl n County Hospital and University Teaching Hospital) (0.0 mi away) Contact
+39 other location
atrophy
aflibercept
aflibercept injection
glaucoma
spectral domain optical coherence tomography
fibrosis
photocoagulation
age-related macular degeneration
pars plana vitrectomy

Summary

This study will evaluate the efficacy and safety of AKST4290 in combination with aflibercept injections in subjects with newly diagnosed neovascular age-related macular degeneration (nAMD).

Description

This is a randomized, double-masked, placebo-controlled, dose-ranging, multicenter study to assess the efficacy and safety of AKST4290 administered orally at 400 mg twice per day or 800 mg b.i.d. in combination with intravitreal aflibercept injections (IAI), in subjects with newly diagnosed neovascular age-related macular degeneration (nAMD) who are nave to treatment with anti-vascular endothelial growth factor (anti-VEGF) medications in the study eye. Subjects will be treated with AKST4290 800 mg daily, 1600 mg daily, or placebo for a total of 36 weeks.

Details
Condition Neovascular Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Neovascular Age Related Macular Degeneration
Treatment Placebo, Aflibercept, AKST4290
Clinical Study IdentifierNCT04331730
SponsorAlkahest, Inc.
Last Modified on27 September 2021

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