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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: NCT03834753
Recruitment Status : Completed
First Posted : February 8, 2019
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
Outlook Therapeutics, Inc.

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : June 25, 2019
Actual Primary Completion Date : June 7, 2021
Actual Study Completion Date : July 8, 2021

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects who gain 15 or more letters 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 [ 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 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.

  3. 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.

  4. 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.

  5. Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse [ Time Frame: 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 [ Time Frame: 11 months, 12 months ]

Eligibility Criteria
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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 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
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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): NCT03834753


Locations
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Sponsors and Collaborators
Outlook Therapeutics, Inc.
Investigators
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Study Director: Jennifer M Kissner, PhD Outlook Therapeutics, Inc.
More Information
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Responsible Party: Outlook Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03834753    
Other Study ID Numbers: ONS-5010-002
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
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
Choroidal Neovascularization
Retinal Degeneration
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