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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)

Primary Purpose

Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
bevacizumab
ranibizumab
Sponsored by
Outlook Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring Subfoveal Choroidal Neovascularization

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

bevacizumab

ranibizumab

Arm Description

ONS-5010

Outcomes

Primary Outcome Measures

Proportion of subjects who gain 15 or more letters in the best corrected visual acuity (BCVA) score
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

Mean change in the best corrected visual acuity over time
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Proportion of participants who gain at least 10 letters in the best corrected visual acuity score
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Proportion of participants who gain at least 5 letters in the best corrected visual acuity score
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score
BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.
Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse
Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities

Full Information

First Posted
February 14, 2019
Last Updated
May 7, 2021
Sponsor
Outlook Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03844074
Brief Title
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
July 23, 2020 (Actual)
Study Completion Date
August 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Outlook Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration
Keywords
Subfoveal Choroidal Neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bevacizumab
Arm Type
Experimental
Arm Description
ONS-5010
Arm Title
ranibizumab
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
ONS-5010
Intervention Description
1.25 mg, intravitreal injection
Intervention Type
Biological
Intervention Name(s)
ranibizumab
Intervention Description
0.5mg, intravitreal injection
Primary Outcome Measure Information:
Title
Proportion of subjects who gain 15 or more letters in the best corrected visual acuity (BCVA) score
Description
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.
Time Frame
Baseline, 11 months
Secondary Outcome Measure Information:
Title
Mean change in the best corrected visual acuity over time
Description
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Time Frame
Baseline, monthly to 11 months
Title
Proportion of participants who gain at least 10 letters in the best corrected visual acuity score
Description
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Time Frame
Baseline, 11 months
Title
Proportion of participants who gain at least 5 letters in the best corrected visual acuity score
Description
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Time Frame
Baseline, 11 months
Title
Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score
Description
BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.
Time Frame
Baseline, 11 months
Title
Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse
Time Frame
Baseline, 11 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer M Kissner, PhD
Organizational Affiliation
Outlook Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Site
City
Hurstville
State/Province
New South Wales
Country
Australia
Facility Name
Clinical Site
City
Liverpool
State/Province
New South Wales
Country
Australia
Facility Name
Clinical Site
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Clinical Site
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Clinical Site
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Clinical Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Clinical Site
City
Hobart
State/Province
Tasmania
Country
Australia
Facility Name
Clinical Site
City
Essendon
State/Province
Victoria
Country
Australia
Facility Name
Clinical Site
City
Glen Waverley
State/Province
Victoria
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will not be shared until all global regulatory filings are complete.

Learn more about this trial

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

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