A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
NCT03834753 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228
Last updated 2025-03-19
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.
Conditions
- Age-related Macular Degeneration
- Neovascular Age-related Macular Degeneration
- Wet Macular Degeneration
Interventions
- BIOLOGICAL
-
1.25 mg, intravitreal injection
- BIOLOGICAL
-
0.5mg, intravitreal injection
Sponsors & Collaborators
-
Outlook Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Jennifer M Kissner, PhD · Outlook Therapeutics, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-25
- Primary Completion
- 2021-06-07
- Completion
- 2021-07-08
- FDA Drug
- Yes
Countries
- United States
Study Locations
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