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出境医 / 临床实验 / Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration

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

Study Description
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
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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
Arms and Interventions
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
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
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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
Contacts and Locations

Locations
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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
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Study Director: Alkahest Medical Monitor Alkahest, Inc.
Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE June 15, 2018
Results First Submitted Date  ICMJE August 13, 2020
Results First Posted Date  ICMJE August 28, 2020
Last Update Posted Date December 16, 2020
Actual Study Start Date  ICMJE April 4, 2018
Actual Primary Completion Date November 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2020) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2018) 		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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2018) 		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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: June 13, 2018)
  • Plasma concentration of ALK4290 [ Time Frame: Baseline to 8 weeks ]
    Assessment of noncompartmental pharmacokinetic analyses of the plasma concentration-time data
  • Central retinal thickness (CRT) [ Time Frame: Baseline to 9 weeks ]
    Changes in CRT as measured by spectral domain optical coherence tomography (SD-OCT)
  • Intraretinal fluid (IRF) [ Time Frame: Baseline to 9 weeks ]
    Changes in IRF as measured by SD-OCT
  • Subretinal fluid (SRF) [ Time Frame: Baseline to 9 weeks ]
    Changes in SRF as measured by SD-OCT
  • Pigment epithelial detachment (PED) [ Time Frame: Baseline to 9 weeks ]
    Changes in PED as measured by SD-OCT
 
Descriptive Information
Brief Title  ICMJE Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration
Official Title  ICMJE 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)
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Wet Age-related Macular Degeneration
Intervention  ICMJE Drug: ALK4290
ALK4290 400 mg tablet twice a day
Other Names:
  • AKST4290
  • BI 144807
Study Arms  ICMJE Experimental: Active
ALK4290 800 mg daily
Intervention: Drug: ALK4290
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2018) 		30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 18, 2018
Actual Primary Completion Date November 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03558061
Other Study ID Numbers  ICMJE ALK4290-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alkahest, Inc.
Study Sponsor  ICMJE Alkahest, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alkahest Medical Monitor Alkahest, Inc.
PRS Account Alkahest, Inc.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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