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

• ClinicalTrials.gov Identifier: NCT03834753
• Recruitment Status: Completed
• First Posted: February 8, 2019
• Last Update Posted: February 17, 2022
• Sponsor: Outlook Therapeutics, Inc.
• Information provided by (Responsible Party): Outlook Therapeutics, Inc.

Tracking Information

• First Submitted Date: February 6, 2019
• First Posted Date: February 8, 2019
• Last Update Posted Date: February 17, 2022
• Actual Study Start Date: June 25, 2019
• Actual Primary Completion Date: June 7, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 17, 2020)

Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA) [ Time Frame: Baseline, 11 months ]

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.

• Original Primary Outcome Measures (submitted: February 6, 2019): Mean change from baseline in best corrected visual acuity score [ Time Frame: Baseline, 10 months ]

Current Secondary Outcome Measures (submitted: June 17, 2020)

• Mean change in the best corrected visual acuity [ Time Frame: Baseline, monthly to 11 months ]
  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 [ Time Frame: Baseline, 11 months ]
  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 [ Time Frame: Baseline, 11 months ]
  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 [ Time Frame: Baseline, 11 months ]
  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 [ Time Frame: Baseline, 11 months ]
• 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 ]

Original Secondary Outcome Measures (submitted: February 6, 2019)

• Mean change in the best corrected visual acuity score over time [ Time Frame: Baseline, monthly to 10 months ]
• Proportion of participants who gain at least 15 letters in the best corrected visual acuity score [ Time Frame: Baseline, 10 months ]
• Proportion of participants who gain at least 10 letters in the best corrected visual acuity score [ Time Frame: Baseline, 10 months ]
• Proportion of participants who gain at least 5 letters in the best corrected visual acuity score [ Time Frame: Baseline, 10 months ]
• Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score [ Time Frame: Baseline, 10 months ]
• Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse [ Time Frame: Baseline, 10 months ]
• Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities [ Time Frame: 10 months, 12 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Age-related Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

• Biological: bevacizumab
  1.25 mg, intravitreal injection
  Other Name: ONS-5010
• Biological: ranibizumab
  0.5mg, intravitreal injection

Study Arms

• Experimental: bevacizumab
  ONS-5010
  Intervention: Biological: bevacizumab
• Active Comparator: ranibizumab
  Intervention: Biological: ranibizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 15, 2022): 228
• Original Estimated Enrollment (submitted: February 6, 2019): 180
• Actual Study Completion Date: July 8, 2021
• Actual Primary Completion Date: June 7, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States
• Removed Location Countries: Australia, New Zealand

Administrative Information

• NCT Number: NCT03834753
• Other Study ID Numbers: ONS-5010-002
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

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

• Current Responsible Party: Outlook Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Outlook Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Jennifer M Kissner, PhD; Outlook Therapeutics, Inc.

• PRS Account: Outlook Therapeutics, Inc.
• Verification Date: February 2022