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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)

Sponsor
Outlook Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03844074
Collaborator
(none)
61
Enrollment
9
Locations
2
Arms
22.4
Actual Duration (Months)
6.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: bevacizumab
  • Biological: ranibizumab
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Oct 1, 2018
Actual Primary Completion Date :
Jul 23, 2020
Actual Study Completion Date :
Aug 13, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: bevacizumab

ONS-5010

Biological: bevacizumab
1.25 mg, intravitreal injection
Other Names:
  • ONS-5010

    		•
    Active Comparator: ranibizumab

    Biological: ranibizumab
    0.5mg, intravitreal injection

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of subjects who gain 15 or more letters in the best corrected visual acuity (BCVA) score [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.

    Secondary Outcome Measures

    1. Mean change in the best corrected visual acuity over time [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.

    2. Proportion of participants who gain at least 10 letters in the best corrected visual acuity score [Baseline, 11 months]

      BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.

    3. Proportion of participants who gain at least 5 letters in the best corrected visual acuity score [Baseline, 11 months]

      BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.

    4. Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score [Baseline, 11 months]

      BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.

    5. Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse [Baseline, 11 months]

    6. Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities [11 months, 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Active primary or recurrent Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye

    • Best corrected visual acuity of 20/40 to 20/320

    • Study eye must:

    • Have active leakage on Fluorescein Angiogram involving the fovea

    • Have edema involving the fovea

    • Be free of foveal scarring

    • Be free of foveal atrophy

    Exclusion Criteria:

    • Previous use of anti-VEGF or bevacizumab within 6 weeks

    • 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) confirmed by indocyanine green angiography (ICGA)

    • 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 or indocyanine green, not amenable to treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Site Hurstville New South Wales Australia
    2 Clinical Site Liverpool New South Wales Australia
    3 Clinical Site Sydney New South Wales Australia
    4 Clinical Site Westmead New South Wales Australia
    5 Clinical Site Brisbane Queensland Australia
    6 Clinical Site Adelaide South Australia Australia
    7 Clinical Site Hobart Tasmania Australia
    8 Clinical Site Essendon Victoria Australia
    9 Clinical Site Glen Waverley Victoria Australia

    Sponsors and Collaborators

    • Outlook Therapeutics, Inc.

    Investigators

    • Study Director: Jennifer M Kissner, PhD, Outlook Therapeutics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Outlook Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03844074
    Other Study ID Numbers:
    • ONS-5010-001
    First Posted:
    Feb 18, 2019
    Last Update Posted:
    May 12, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Outlook Therapeutics, Inc.
    Subfoveal Choroidal Neovascularization
    Additional relevant MeSH terms:
    Macular Degeneration
    Wet Macular Degeneration
    Choroidal Neovascularization
    Bevacizumab
    Ranibizumab

    Study Results

    No Results Posted as of May 12, 2021