A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders

Last updated: March 17, 2025
Sponsor: Outlook Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Diabetic Macular Edema

Macular Degeneration

Aging

Treatment

bevacizumab

Clinical Study ID

NCT04516278
ONS-5010-003
  • Ages > 18
  • All Genders

Study Summary

The study will evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Active clinical diagnosis and OCT confirmation of one of the following retinaldisorders: exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or branch retinal vein occlusion (BRVO) and, in the opinion of theInvestigator, requires treatment with an anti-VEGF therapy

Exclusion

Exclusion Criteria:

  • Previous use of approved anti-VEGF or Avastin® within 4 weeks precedingrandomization

  • Macular edema due to something other than exudative AMD, DME or BRVO, in the studyeye

  • History of inadequate response to previous intravitreal anti-VEGF therapy

  • History of any intraocular or periocular corticosteroid injection or implant, in thestudy eye

  • Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-monthpreceding randomization

  • Any concurrent intraocular condition in the study eye that may require medical orsurgical intervention or contribute to vision loss during the study period

  • Active intraocular inflammation in the study eye

  • Current vitreous hemorrhage in the study eye

  • Polypoidal choroidal vasculopathy (PCV) in the study eye

  • History of idiopathic, infectious or autoimmune-associated uveitis in either eye

  • Current ocular or periocular infection, such as conjunctivitis, keratitis,scleritis, or endophthalmitis in either eye

  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHgdespite 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 , not amenable to treatment

Study Design

Total Participants: 195
Treatment Group(s): 1
Primary Treatment: bevacizumab
Phase: 3
Study Start date:
October 01, 2020
Estimated Completion Date:
February 10, 2021

Connect with a study center

  • Clinical Site

    Tucson, Arizona 85710
    United States

    Site Not Available

  • Clinical Site

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Clinical Site

    Glendale, California 91203
    United States

    Site Not Available

  • Clinical Site

    Long Beach, California 90807
    United States

    Site Not Available

  • Clinical Site

    Palm Desert, California 92260
    United States

    Site Not Available

  • Clinical Site

    Poway, California 92064
    United States

    Site Not Available

  • Clinical Site

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Clinical Site

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Clinical Site

    Oak Forest, Illinois 60452
    United States

    Site Not Available

  • Clinical Site

    Springfield, Illinois 62704
    United States

    Site Not Available

  • Clinical Site

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Clinical Site

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Clinical Site

    Chambersburg, Pennsylvania 17201
    United States

    Site Not Available

  • Clinical Site

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Clinical Site

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Clinical Site

    Abilene, Texas 79606
    United States

    Site Not Available

  • Clinical Site

    Arlington, Texas 76012
    United States

    Site Not Available

  • Clinical Site

    McAllen, Texas 78503
    United States

    Site Not Available

  • Clinical Site

    San Antonio, Texas 78251
    United States

    Site Not Available

  • Clinical Site

    Willow Park, Texas 76087
    United States

    Site Not Available

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