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Evaluate the Therapeutic Effects and Safety of ALK4290 in Patients With Refractory 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. Identifier: NCT03558074
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : December 6, 2018
Information provided by (Responsible Party):
Alkahest, Inc.

Brief Summary:
This study will evaluate the therapeutic effects and safety of 800 mg ALK4290 administered daily over a 6-week dosing period in subjects with refractory 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 investigate the potential therapeutic effects and safety of oral ALK4290 administered 800 mg daily over a 6-week dosing period as measured by Best Corrected Visual Acuity (BCVA) in subjects with refractory wAMD (i.e., following monthly intravitreal [IVT] anti-VEGF therapy for at least 3 months in the study eye).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
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 Refractory Wet Age-Related Macular Degeneration (wAMD)
Actual Study Start Date : April 20, 2018
Actual Primary Completion Date : November 29, 2018
Actual Study Completion Date : November 29, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active
ALK4290 800 mg daily (400 mg tablet twice a day)
Drug: ALK4290
ALK4290 400 mg tablet twice a day

Primary Outcome Measures :
  1. Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline to 6 weeks ]
    Mean changes in BCVA as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) testing method

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)

Other Outcome Measures:
  1. Plasma concentration of ALK4290 [ Time Frame: Baseline to 8 weeks ]
    Assessment of noncompartmental pharmacokinetic analyses of the plasma concentration time data

  2. Central retinal thickness (CRT) [ Time Frame: Baseline to 9 weeks ]
    Changes in CRT as measured by spectral domain optical coherence tomography (SD-OCT)

  3. Intraretinal fluid (IRF) [ Time Frame: Baseline to 9 weeks ]
    Changes in IRF as measured by SD-OCT

  4. Subretinal fluid (SRF) [ Time Frame: Baseline to 9 weeks ]
    Changes in SRF as measured by SD-OCT

  5. Pigment epithelial detachment (PED) [ Time Frame: Baseline to 9 weeks ]
    Changes in PED as measured by SD-OCT

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Men and women with refractory active CNV secondary to AMD, diagnosed by a retinal specialist with all the following characteristics and ophthalmic inclusion criteria applied to the study eye:

    • Persistent exudation of SRF and IRF as documented by SD-OCT and absence of improvement in visual acuity following monthly IVT anti-VEGF therapy of at least 3 months; subject must have received their last IVT anti-VEGF injection 30 to 90 days prior to the initial screening visit
    • Central subfield retinal thickness ≥ 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF)
    • 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. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in the study, she should inform her treating physician immediately
  • 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:

  • Treatment with IVT anti-VEGF therapy within 30 days preceding screening visit in the study eye and/or planned concomitant IVT anti-VEGF treatment in the fellow eye during the study period
  • 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)
  • 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

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 identifier (NCT number): NCT03558074

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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.
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Study Director: Alkahest Medical Monitor Alkahest, Inc.

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Responsible Party: Alkahest, Inc. Identifier: NCT03558074     History of Changes
Other Study ID Numbers: ALK4290-202
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Alkahest, Inc.:
Refractory wAMD
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases