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A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders (NORSE SEVEN)

Primary Purpose

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

Status
Active
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
  • Previous use of Beovu®
  • 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

  • Clinical Site
  • Clinical Site
  • Clinical Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biological: bevacizumab

Arm Description

Outcomes

Primary Outcome Measures

Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or PFS

Secondary Outcome Measures

Full Information

First Posted
October 28, 2021
Last Updated
March 28, 2023
Sponsor
Outlook Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05112861
Brief Title
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
Acronym
NORSE SEVEN
Official Title
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus PFS in Subjects With Visual Impairment Due to Retinal Disorders, NORSE SEVEN
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

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 compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes 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
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biological: bevacizumab
Arm Type
Experimental
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 following intravitreal injections of ONS-5010 in vials or PFS
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 Previous use of Beovu® 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
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
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders

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