Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03558061
Recruitment Status : Completed
First Posted : June 15, 2018
Results First Posted : August 28, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Alkahest, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Wet Age-related Macular Degeneration Drug: ALK4290 Phase 2

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 4, 2018
Actual Primary Completion Date : November 18, 2018
Actual Study Completion Date : November 18, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Active
ALK4290 800 mg daily
 Drug: ALK4290
ALK4290 400 mg tablet twice a day
Other Names:
  • AKST4290
  • BI 144807


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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. The ETDRS chart assesses changes in vision based on the number of letters correctly read by the subject.


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558061


Locations
Layout table for location information
Hungary
Jahn Ferenc South-Pest Hospital and Clinic
Budapest, Hungary
Borsod-Abauj-Zemplen County Hospital and Teaching Hospital
Miskolc, Hungary
Szabolcs-Szatmar-Bereg County Hospital and University Hospital
Nyíregyháza, Hungary
University of Szeged Faculty of Medicine
Szeged, Hungary
Markusovszky University Teaching Hospital
Szombathely, Hungary
Sponsors and Collaborators
Alkahest, Inc.
Investigators
Layout table for investigator information
Study Director: Alkahest Medical Monitor Alkahest, Inc.
  Study Documents (Full-Text)

Documents provided by Alkahest, Inc.:
Study Protocol  [PDF] May 15, 2018
Statistical Analysis Plan  [PDF] August 20, 2018

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Alkahest, Inc.
ClinicalTrials.gov Identifier: NCT03558061    
Other Study ID Numbers: ALK4290-201
First Posted: June 15, 2018    Key Record Dates
Results First Posted: August 28, 2020
Last Update Posted: December 16, 2020
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases