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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Alkahest, Inc.
Study ID
NCT04331730
Phase
PHASE2
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AKST4290 — DRUG
    Oral AKST4290
  • Placebo — DRUG
    Oral placebo
  • Aflibercept — DRUG
    Aflibercept intravitreal injection

Study Details

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).

Key Dates

Start date
Jan 28, 2020
Status verified
Oct 2022
Primary completion
Aug 19, 2021
Completion
Sep 16, 2021

Study Design

Enrollment
107 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AKST4290 (800 mg) + Aflibercept
    Subjects will receive 400 mg AKST4290 twice daily for 36 weeks, in combination with intravitreal aflibercept injection treatment
  • Experimental: AKST4290 (1600 mg) + Aflibercept
    Subjects will receive 800 mg AKST4290 twice daily for 36 weeks, in combination with intravitreal aflibercept injection treatment
  • Placebo Comparator: Placebo + Aflibercept
    Subjects will receive placebo for 36 weeks, in combination with intravitreal aflibercept injection treatment

Primary Outcome Measure

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Per the Early Treatment Diabetic Retinopathy Study (ETDRS) Testing Method [ Time Frame: Baseline to Week 36 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Retina Vitreous Associates of FLSt. PetersburgFlorida33711-
Sierra Eye AssociatesRenoNevada89502-

Find similar trials in Beverly Hills, CA

By research site
Retina-Vitreous Associates Medical Group· Beverly Hills, CARetina Vitreous Associates of FL· St. Petersburg, FLSierra Eye Associates· Reno, NV

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