Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration

Overview

This study will evaluate the therapeutic effects and safety of 800 mg ALK4290 administered daily over a 6-week dosing period in newly diagnosed patients with wet age-related macular degeneration (wAMD).

Full Title of Study: “A Single Arm Open-Label Study to Evaluate the Therapeutic Effects and Safety of a 6-Week Treatment Regimen of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration (wAMD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 18, 2018

Detailed Description

This study is designed to evaluate the therapeutic effects and safety of oral ALK4290 administered at 800 mg daily over a 6-week dosing period in newly diagnosed (treatment naïve) patients with wAMD. The study agent will be orally self-administered. All subjects will receive the study agent, ALK4290. This study does not contain a placebo.

Interventions

  • Drug: ALK4290
    • ALK4290 400 mg tablet twice a day

Arms, Groups and Cohorts

  • Experimental: Active
    • ALK4290 800 mg daily (400 mg tablet twice a day)

Clinical Trial Outcome Measures

Primary Measures

  • Best corrected visual acuity (BCVA)
    • Time Frame: Baseline to 6 weeks
    • Mean change in BCVA letter score as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) method

Secondary Measures

  • Incidence of treatment-emergent adverse events (safety)
    • Time Frame: Baseline to 10 weeks
    • Treatment-emergent adverse events identified by the Common Terminology Criteria for Adverse Events (CTCAE v4.03)

Participating in This Clinical Trial

Inclusion Criteria

  • Men and women with newly diagnosed active CNV secondary to AMD, diagnosed by a retinal specialist with all the following characteristics and ophthalmic inclusion criteria applied to the study eye:
  • No prior treatment for wAMD in the study eye and no current or planned concomitant intravitreal anti-VEGF treatment in the fellow eye
  • Central subfield retinal thickness ≥ 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF)
  • Presence of SRF and/or IRF on SD-OCT
  • Any active CNV with subfoveal leakage as determined by FA
  • Total lesion size not greater than 12 disc areas on FA
  • If present, subretinal hemorrhage must comprise < 50% of the total lesion area on FA
  • No subfoveal fibrosis or atrophy on FA
  • BCVA letter score, as measured by ETDRS in the study eye, between 70 and 24 letters, inclusive, at screening
  • Patients 50 years of age or older at screening visit 1
  • Body mass index (BMI) between18 and ≤ 40 at screening visit 1
  • Female subjects must not be pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry.
  • Signed informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions

Exclusion Criteria

  • Previous participation in any studies of investigational drugs within 1 month preceding screening visit
  • Any form of macular degeneration that is not age-related (e.g., Best's disease, Stargardt's disease, Sorsby's disease, etc.)
  • Additional eye disease in the study eye that could compromise BCVA (i.e., uncontrolled glaucoma (intraocular pressure > 24) with visual field loss, clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinal vascular occlusion, vitreomacular traction, monocular vision, or genetic disorders such as retinitis pigmentosa; high myopia > 8 diopters)
  • The presence of polypoidal choroidal vasculopathy (PCV) or retinal angiomatous proliferation (RAP) in the study eye
  • Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with fundus photography/FA or SD-OCT
  • Intraocular surgery in the study eye within 3 months prior to screening
  • Aphakia or total absence of the posterior capsule (yttrium aluminum garnet (YAG) laser capsulotomy permitted, a minimum of 1 month prior to enrollment) in the study eye

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alkahest, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alkahest Medical Monitor, Study Director, Alkahest, Inc.

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