A 3-month Study to Assess the Safety and Effectiveness 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

Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.

Key Dates

First listed

Jan 5, 2024

Start date

Jan 24, 2024

Status verified

Jun 2026

Primary completion

Nov 7, 2024

Completion

Dec 5, 2024

Study Design

Enrollment

400 participants (actual)

Allocation

NA

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

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 ]

Locations (61)

Find similar trials in Arcadia, CA

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