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A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders

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NCT05112861 · readout ≤ 499 d

Sponsored by Outlook Therapeutics, Inc. (industry) · OTLK — their whole pipeline →.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
120estimated
Sites
3
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2021-11-15actualWhen the study began enrolling
Primary completionDec 2027estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionDec 2027estimatedThe whole study's end, after follow-up
First posted2021-11-09actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-04-22actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Age-Related Macular Degeneration
  • Neovascular Age-related Macular Degeneration
  • Wet Macular Degeneration
  • BRVO - Branch Retinal Vein Occlusion
  • Diabetic Macular Edema

Intervention

  • Biological: bevacizumab — also filed as ONS-5010

Primary outcome

what the primary-completion date above is the date OF
Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or PFS
measured 3 months

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