A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)

May 7, 2021 updated by: Outlook Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • 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
        • Clinical Site
    • Queensland
      • Brisbane, Queensland, Australia
        • Clinical Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Clinical Site
    • Tasmania
      • Hobart, Tasmania, Australia
        • Clinical Site
    • Victoria
      • Essendon, Victoria, Australia
        • Clinical Site
      • Glen Waverley, Victoria, Australia
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects who gain 15 or more letters in the best corrected visual acuity (BCVA) score
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.
Baseline, 11 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse
Time Frame: Baseline, 11 months
Baseline, 11 months
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
11 months, 12 months
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.
Baseline, monthly to 11 months
Proportion of participants who gain at least 10 letters in the best corrected visual acuity score
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.
Baseline, 11 months
Proportion of participants who gain at least 5 letters in the best corrected visual acuity score
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.
Baseline, 11 months
Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score
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.
Baseline, 11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Outlook Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2018

Primary Completion (ACTUAL)

July 23, 2020

Study Completion (ACTUAL)

August 13, 2020

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (ACTUAL)

February 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONS-5010-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will not be shared until all global regulatory filings are complete.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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