ONS-5010 for Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

+60 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Outlook Therapeutics, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Research Team

Eligibility Criteria

This trial is for people with a specific eye condition called neovascular Age-related Macular Degeneration (AMD). Participants must have swelling in the central part of their retina, no scarring or atrophy in that area, active blood vessel growth under the retina due to AMD, and a certain level of vision acuity. They should also show active leakage on an eye test called Fluorescein Angiogram.

Inclusion Criteria

Your vision with glasses or contacts is between 20/32 and 20/200 on the eye chart.

I have swelling in the central part of my retina.

I have wet AMD with active lesions in the center of my vision.

See 2 more

Treatment Details

Interventions

bevacizumab (Anti-VEGF)
ranibizumab (Anti-VEGF)

Trial OverviewThe study is testing ONS-5010's safety and effectiveness compared to other treatments like ranibizumab and bevacizumab. It involves injecting ONS-5010 into the eye to see if it can help with AMD. The trial will randomly assign participants to different treatment groups without them knowing which one they're in.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: ONS-5010 bevacizumabExperimental Treatment1 Intervention

Group II: ranibizumabActive Control1 Intervention