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

Conditions

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

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

Start date

Jun 25, 2019

Status verified

Mar 2025

Primary completion

Jun 7, 2021

Completion

Jul 8, 2021

Study Design

Enrollment

228 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 best corrected visual acuity (BCVA) [ Time Frame: Baseline, 11 months ]

Locations (50)

Find similar trials in Tucson, AZ

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