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
NCT03834753
Collaborator
(none)
228
50
2
24.4
4.6
0.2

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 :
228 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 :
Jun 25, 2019
Actual Primary Completion Date :
Jun 7, 2021
Actual Study Completion Date :
Jul 8, 2021

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 best corrected visual acuity (BCVA) [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 [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 [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 [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 [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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Site Tucson Arizona United States 85710
    2 Clinical Site Arcadia California United States 91007
    3 Clinical Site Beverly Hills California United States 90211
    4 Clinical Site Campbell California United States 95008
    5 Clinical Site Glendale California United States 91203
    6 Clinical Site Laguna Hills California United States 92653
    7 Clinical Site Long Beach California United States 90807
    8 Clinical Site Mountain View California United States 94040
    9 Clinical Site Oxnard California United States 93036
    10 Clinical Site Palm Desert California United States 92260
    11 Clinical Site Poway California United States 92064
    12 Clinical Site Sacramento California United States 95841
    13 Clinical Site Santa Maria California United States 93454
    14 Clinical Site Tustin California United States 92780
    15 Clinical Site Golden Colorado United States 80401
    16 Clinical Site Hamden Connecticut United States 06518
    17 Clinical Site Clearwater Florida United States 33761
    18 Clinical Site Pinellas Park Florida United States 33782
    19 Clinical Site Sarasota Florida United States 24233
    20 Clinical Site Winter Haven Florida United States 33880
    21 Clinical Site Augusta Georgia United States 30909
    22 Clinical Site Marietta Georgia United States 30060
    23 Clinical Site Downers Grove Illinois United States 60615
    24 Clinical Site Lemont Illinois United States 60439
    25 Clinical Site Springfield Illinois United States 62704
    26 Clinical Site Indianapolis Indiana United States 46290
    27 Clinical Site Hagerstown Maryland United States 21740
    28 Clinical Site Edina Minnesota United States 55435
    29 Clinical Site Saint Louis Missouri United States 63144
    30 Clinical Site Bloomfield New Jersey United States 07003
    31 Clinical Site Albuquerque New Mexico United States 87109
    32 Clinical Site New York New York United States 10021
    33 Clinical Site Chambersburg Pennsylvania United States 17201
    34 Clinical Site Monroeville Pennsylvania United States 15146
    35 Clinical Site Rapid City South Dakota United States 57701
    36 Clinical Site Germantown Tennessee United States 38138
    37 Clinical Site Abilene Texas United States 79606
    38 Clinical Site Amarillo Texas United States 79106
    39 Clinical Site Arlington Texas United States 76012
    40 Clinical Site Dallas Texas United States 75231
    41 Clinical Site Grapevine Texas United States 76051
    42 Clinical Site Houston Texas United States 77030
    43 Clinical Site McAllen Texas United States 78503
    44 Clinical Site San Antonio Texas United States 78240
    45 Clinical Site San Antonio Texas United States 78251
    46 Clinical Site The Woodlands Texas United States 77384
    47 Clinical Site Willow Park Texas United States 76807
    48 Clinical Site Salt Lake City Utah United States 84107
    49 Clinical Site Norfolk Virginia United States 23502
    50 Clinical Site Madison Wisconsin United States 53705

    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:
    NCT03834753
    Other Study ID Numbers:
    • ONS-5010-002
    First Posted:
    Feb 8, 2019
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    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.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2022