- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03558061
Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration
November 23, 2020 updated by: Alkahest, Inc.
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)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Budapest, Hungary
- Jahn Ferenc South-Pest Hospital and Clinic
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Miskolc, Hungary
- Borsod-Abaúj-Zemplén County Hospital and Teaching Hospital
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Nyíregyháza, Hungary
- Szabolcs-Szatmar-Bereg County Hospital and University Hospital
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Szeged, Hungary
- University of Szeged Faculty of Medicine
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Szombathely, Hungary
- Markusovszky University Teaching Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active
ALK4290 800 mg daily
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ALK4290 400 mg tablet twice a day
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Baseline to 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 4, 2018
Primary Completion (Actual)
November 18, 2018
Study Completion (Actual)
November 18, 2018
Study Registration Dates
First Submitted
May 15, 2018
First Submitted That Met QC Criteria
June 13, 2018
First Posted (Actual)
June 15, 2018
Study Record Updates
Last Update Posted (Actual)
December 16, 2020
Last Update Submitted That Met QC Criteria
November 23, 2020
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALK4290-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on ALK4290
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Alkahest, Inc.CompletedWet Age-related Macular DegenerationHungary