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A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834753
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Outlook Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE February 6, 2019
First Posted Date  ICMJE February 8, 2019
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE June 25, 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
Mean change from baseline in best corrected visual acuity (BCVA) [ Time Frame: Baseline, 11 months ]
BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
Mean change from baseline in best corrected visual acuity score [ Time Frame: Baseline, 10 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Proportion of participants who gain at least 5 letters in the best corrected visual acuity [ Time Frame: Baseline, 11 months ]
    BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
  • Proportion of participants who gain at least 10 letters in the best corrected visual acuity [ Time Frame: Baseline, 11 months ]
    BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
  • Proportion of participants who gain at least 15 letters in the best corrected visual acuity [ Time Frame: Baseline, 11 months ]
    BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
  • Mean change in the best corrected visual acuity over time [ Time Frame: Baseline, monthly to 11 months ]
    BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
  • Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity [ Time Frame: Baseline, 11 months ]
    BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.
  • Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse [ Time Frame: Baseline, 11 months ]
  • Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities [ Time Frame: 11 months, 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
  • Mean change in the best corrected visual acuity score over time [ Time Frame: Baseline, monthly to 10 months ]
  • Proportion of participants who gain at least 15 letters in the best corrected visual acuity score [ Time Frame: Baseline, 10 months ]
  • Proportion of participants who gain at least 10 letters in the best corrected visual acuity score [ Time Frame: Baseline, 10 months ]
  • Proportion of participants who gain at least 5 letters in the best corrected visual acuity score [ Time Frame: Baseline, 10 months ]
  • Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score [ Time Frame: Baseline, 10 months ]
  • Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse [ Time Frame: Baseline, 10 months ]
  • Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities [ Time Frame: 10 months, 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Official Title  ICMJE A Clinical Effectiveness, Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration
Brief Summary This research study will examine the safety and effectiveness of ONS-5010 in participants with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as compared with ranibizumab.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Age-related Macular Degeneration
  • Neovascular Age-related Macular Degeneration
  • Wet Macular Degeneration
Intervention  ICMJE
  • Biological: bevacizumab
    1.25 mg, intravitreal injection
    Other Name: ONS-5010
  • Biological: ranibizumab
    0.5mg, intravitreal injection
Study Arms  ICMJE
  • Experimental: bevacizumab
    ONS-5010
    Intervention: Biological: bevacizumab
  • Active Comparator: ranibizumab
    Intervention: Biological: ranibizumab
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019)
220
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2019)
180
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
  • Best corrected visual acuity of 25-67 letters read (20/50 to 20/320 Snellen equivalent)
  • Study eye must:

    • Have active leakage on Fluorescein Angiogram involving the fovea
    • Have edema involving the fovea
    • Be free of scarring, fibrosis, or atrophy involving the central foveal zone

Exclusion Criteria:

  • Previous subfoveal focal laser photocoagulation in the study eye
  • Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
  • Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year
  • Active intraocular inflammation (grade trace or above) in the study eye
  • Current vitreous haemorrhage in the study eye
  • Polypoidal choroidal vasculopathy (PCV) in the study eye
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
  • Premenopausal women not using adequate contraception
  • Current treatment for active systemic infection
  • Known allergy to any component of the study drug or history of allergy to fluorescein , not amenable to treatment
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: Clinical Operations +1 (609) 619-3984 ClinicalStudies@outlooktherapeutics.com
Contact: GreenLight Clinical +61 2 9191 0640
Listed Location Countries  ICMJE United States
Removed Location Countries Australia,   New Zealand
 
Administrative Information
NCT Number  ICMJE NCT03834753
Other Study ID Numbers  ICMJE ONS-5010-002
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Data will not be shared until all global regulatory filings are complete.
Responsible Party Outlook Therapeutics, Inc.
Study Sponsor  ICMJE Outlook Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jennifer M Kissner, PhD Outlook Therapeutics, Inc.
PRS Account Outlook Therapeutics, Inc.
Verification Date March 2020

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