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

Sponsor
Outlook Therapeutics, Inc.
Study ID
NCT03844074
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    1.25 mg, intravitreal injection
  • ranibizumab — BIOLOGICAL
    0.5mg, intravitreal injection

Study Details

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.

Key Dates

First listed
Feb 18, 2019
Start date
Oct 1, 2018
Status verified
Mar 2025
Primary completion
Jul 23, 2020
Completion
Aug 13, 2020

Study Design

Enrollment
61 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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

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