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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03844074
Recruitment Status : Active, not recruiting
First Posted : February 18, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Outlook Therapeutics, Inc.

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
Age-related Macular Degeneration Neovascular Age-related Macular Degeneration Wet Macular Degeneration Biological: bevacizumab Biological: ranibizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : October 1, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Experimental: bevacizumab
ONS-5010
Biological: bevacizumab
1.25 mg, intravitreal injection
Other Name: ONS-5010

Active Comparator: ranibizumab Biological: ranibizumab
0.5mg, intravitreal injection




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse [ Time Frame: Baseline, 11 months ]
  7. 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 ]


Information from the National Library of Medicine

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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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844074


Locations
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Australia, New South Wales
Clinical Site
Hurstville, New South Wales, Australia
Clinical Site
Liverpool, New South Wales, Australia
Clinical Site
Sydney, New South Wales, Australia
Clinical Site
Westmead, New South Wales, Australia
Australia, Queensland
Clinical Site
Brisbane, Queensland, Australia
Australia, South Australia
Clinical Site
Adelaide, South Australia, Australia
Australia, Tasmania
Clinical Site
Hobart, Tasmania, Australia
Australia, Victoria
Clinical Site
Essendon, Victoria, Australia
Clinical Site
Glen Waverley, Victoria, Australia
Sponsors and Collaborators
Outlook Therapeutics, Inc.
Investigators
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Study Director: Jennifer M Kissner, PhD Outlook Therapeutics, Inc.

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Responsible Party: Outlook Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03844074     History of Changes
Other Study ID Numbers: ONS-5010-001
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will not be shared until all global regulatory filings are complete.

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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:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Choroidal Neovascularization
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Bevacizumab
Ranibizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors