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

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ClinicalTrials.gov Identifier: NCT03558061
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
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 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 Newly Diagnosed Wet Age-Related Macular Degeneration (wAMD)
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 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 change in BCVA letter score as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) 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
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

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


Contacts
Contact: Alkahest Medical Monitor 650-801-0474 trials@alkahest.com

Locations
Hungary
Jahn Ferenc South-Pest Hospital and Clinic Recruiting
Budapest, Hungary
Contact: Zsuzsanna Oláh, MD       olahzsuzsanna@outlook.hu   
Borsod-Abauj-Zemplen County Hospital and Teaching Hospital Recruiting
Miskolc, Hungary
Contact: Vargáné Ríz Adrienn       radri.szemesz@bazmkorhaz.hu   
Szabolcs-Szatmar-Bereg County Hospital and University Hospital Recruiting
Nyíregyháza, Hungary
Contact: Vida Katalin       vidakatalin@josa.hu   
University of Szeged Faculty of Medicine Recruiting
Szeged, Hungary
Contact: Klára Somlai       somlai.klara@med.u-szeged.hu   
Markusovszky University Teaching Hospital Recruiting
Szombathely, Hungary
Contact: Edina Joo       joo.edina@indamail.hu   
Sponsors and Collaborators
Alkahest, Inc.
Investigators
Study Director: Alkahest Medical Monitor Alkahest, Inc.

Responsible Party: Alkahest, Inc.
ClinicalTrials.gov Identifier: NCT03558061     History of Changes
Other Study ID Numbers: ALK4290-201
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases