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History of Changes for Study: NCT06190093
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Latest version (submitted May 9, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 19, 2023 None (earliest Version on record)
2 January 25, 2024 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 February 5, 2024 Study Status and Contacts/Locations
4 February 21, 2024 Contacts/Locations and Study Status
5 February 26, 2024 Contacts/Locations and Study Status
6 February 28, 2024 Contacts/Locations and Study Status
7 February 29, 2024 Study Status
8 March 1, 2024 Study Status and Contacts/Locations
9 March 1, 2024 Contacts/Locations and Study Status
10 March 7, 2024 Contacts/Locations and Study Status
11 March 8, 2024 Contacts/Locations and Study Status
12 March 8, 2024 Contacts/Locations and Study Status
13 March 12, 2024 Contacts/Locations and Study Status
14 March 13, 2024 Contacts/Locations and Study Status
15 March 18, 2024 Contacts/Locations and Study Status
16 March 19, 2024 Contacts/Locations and Study Status
17 March 20, 2024 Contacts/Locations and Study Status
18 March 21, 2024 Contacts/Locations and Study Status
19 March 22, 2024 Contacts/Locations and Study Status
20 March 25, 2024 Contacts/Locations and Study Status
21 March 26, 2024 Contacts/Locations and Study Status
22 March 27, 2024 Contacts/Locations and Study Status
23 March 28, 2024 Contacts/Locations and Study Status
24 March 29, 2024 Contacts/Locations and Study Status
25 April 3, 2024 Study Status and Contacts/Locations
26 April 10, 2024 Contacts/Locations and Study Status
27 April 15, 2024 Contacts/Locations and Study Status
28 April 23, 2024 Contacts/Locations and Study Status
29 April 26, 2024 Study Status
30 May 3, 2024 Study Status and Contacts/Locations
31 May 9, 2024 Contacts/Locations and Study Status
Comparison Format:
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Changes (Merged) for Study: NCT06190093
December 19, 2023 (v1) -- January 25, 2024 (v2)

Changes in: Study Status, Oversight and Contacts/Locations
Open or close this module Study Identification
Unique Protocol ID: ONS-5010-008
Brief Title: A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Official Title: Safety and Effectiveness of ONS-5010 Compared to Lucentis® in Subjects With Neovascular Age-related Macular Degeneration; NORSE EIGHT
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2023 January 2024
Overall Status: Not yet recruiting Recruiting
Study Start: January 24, 2024
Primary Completion: September 2024 [Anticipated]
Study Completion: October 2024 [Anticipated]
First Submitted: December 19, 2023
First Submitted that
Met QC Criteria:		 December 19, 2023
First Posted: January 5, 2024 [Actual]
Last Update Submitted that
Met QC Criteria:		 December 19, 2023 January 25, 2024
Last Update Posted: January 5 26, 2024 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Outlook Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.
Detailed Description:
Open or close this module Conditions
Conditions: Neovascular Age-related Macular Degeneration
Age-Related Macular Degeneration
Wet Macular Degeneration
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 400 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ONS-5010 bevacizumab Biological: bevacizumab
1.25 mg, intravitreal injection
Other Names:
  • ONS-5010
Active Comparator: ranibizumab Biological: ranibizumab
0.5mg, intravitreal injection
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Evaluate the effectiveness of intravitreal injections of ONS-5010 compared to ranibizumab in preventing vision loss, as measured by the mean change in baseline best correct visual acuity (BCVA) at Week 8
[ Time Frame: Baseline, 8 weeks ]

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.
Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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 35-75 letters read (20/32 to 20/200 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 hemorrhage 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
Open or close this module Contacts/Locations
Central Contact Person: SVP, Clinical & Regulatory Affairs
Telephone: 6154232150
Email: Jenniferkissner@outlooktherapeutics.com
Locations: United States, Texas
Clinical Site
[Recruiting]
Dallas, Texas, United States, 75231
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services