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A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders

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
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

Eligibility Criteria

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

Inclusion Criteria:

  • Active clinical diagnosis and OCT confirmation of one of the following retinal disorders: exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or branch retinal vein occlusion (BRVO) and, in the opinion of the Investigator, requires treatment with an anti-VEGF therapy

Exclusion Criteria:

  • Previous use of approved anti-VEGF or Avastin® within 4 weeks preceding randomization
  • Macular edema due to something other than exudative AMD, DME or BRVO, in the study eye
  • History of inadequate response to previous intravitreal anti-VEGF therapy
  • History of any intraocular or periocular corticosteroid injection or implant, 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 during the study period
  • Active intraocular inflammation in the study eye
  • Current vitreous hemorrhage in the study eye
  • Polypoidal choroidal vasculopathy (PCV) in the study eye
  • History of idiopathic, infectious or autoimmune-associated uveitis in either eye
  • Current ocular or periocular infection, such as 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 , not amenable to treatment

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biological: bevacizumab

Arm Description

ONS-5010

Outcomes

Primary Outcome Measures

Frequency and incidence of treatment-emergent adverse events

Secondary Outcome Measures

Full Information

First Posted
August 13, 2020
Last Updated
November 16, 2021
Sponsor
Outlook Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04516278
Brief Title
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
Official Title
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders, NORSE THREE
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 10, 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
The study will evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.

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, BRVO - Branch Retinal Vein Occlusion, Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biological: bevacizumab
Arm Type
Experimental
Arm Description
ONS-5010
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
ONS-5010
Intervention Description
1.25 mg, intravitreal injection
Primary Outcome Measure Information:
Title
Frequency and incidence of treatment-emergent adverse events
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active clinical diagnosis and OCT confirmation of one of the following retinal disorders: exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or branch retinal vein occlusion (BRVO) and, in the opinion of the Investigator, requires treatment with an anti-VEGF therapy Exclusion Criteria: Previous use of approved anti-VEGF or Avastin® within 4 weeks preceding randomization Macular edema due to something other than exudative AMD, DME or BRVO, in the study eye History of inadequate response to previous intravitreal anti-VEGF therapy History of any intraocular or periocular corticosteroid injection or implant, 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 during the study period Active intraocular inflammation in the study eye Current vitreous hemorrhage in the study eye Polypoidal choroidal vasculopathy (PCV) in the study eye History of idiopathic, infectious or autoimmune-associated uveitis in either eye Current ocular or periocular infection, such as 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 , not amenable to treatment
Facility Information:
Facility Name
Clinical Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
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
Glendale
State/Province
California
ZIP/Postal Code
91203
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
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
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
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
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Facility Name
Clinical Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Clinical Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
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
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
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
Arlington
State/Province
Texas
ZIP/Postal Code
76012
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
78251
Country
United States
Facility Name
Clinical Site
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders

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