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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
United States
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 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

Sites / Locations

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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 best corrected visual acuity (BCVA)
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
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
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
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
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 6, 2019
Last Updated
February 15, 2022
Sponsor
Outlook Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03834753
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
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
June 7, 2021 (Actual)
Study Completion Date
July 8, 2021 (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
No

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
228 (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 best corrected visual acuity (BCVA)
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
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
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
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
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 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
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
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Clinical Site
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Clinical Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Clinical Site
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Clinical Site
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
Facility Name
Clinical Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Clinical Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Clinical Site
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Clinical Site
City
Oxnard
State/Province
California
ZIP/Postal Code
93036
Country
United States
Facility Name
Clinical Site
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Clinical Site
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Clinical Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95841
Country
United States
Facility Name
Clinical Site
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Clinical Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Clinical Site
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Clinical Site
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Clinical Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Clinical Site
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Clinical Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
24233
Country
United States
Facility Name
Clinical Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Clinical Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Clinical Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Clinical Site
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60615
Country
United States
Facility Name
Clinical Site
City
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
Country
United States
Facility Name
Clinical Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Clinical Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Clinical Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Clinical Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Clinical Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63144
Country
United States
Facility Name
Clinical Site
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
Clinical Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Clinical Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Clinical Site
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States
Facility Name
Clinical Site
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
Clinical Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Clinical Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Clinical Site
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Clinical Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Clinical Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Clinical Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Clinical Site
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Clinical Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Site
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Clinical Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Clinical Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Facility Name
Clinical Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Clinical Site
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76807
Country
United States
Facility Name
Clinical Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Clinical Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Clinical Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

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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