A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Outlook Therapeutics, Inc.
Study ID
NCT04516278
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — BIOLOGICAL
    1.25 mg, intravitreal injection

Study Details

The study will evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.

Key Dates

First listed
Aug 18, 2020
Start date
Oct 1, 2020
Status verified
Mar 2025
Primary completion
Feb 10, 2021
Completion
Feb 10, 2021

Study Design

Enrollment
195 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Biological: bevacizumab
    ONS-5010

Primary Outcome Measure

Frequency and incidence of treatment-emergent adverse events [ Time Frame: 3 months ]

Locations (20)

FacilityCityStateZIPSite coordinators
Clinical SiteTucsonArizona85710-
Clinical SiteBeverly HillsCalifornia90211-
Clinical SiteGlendaleCalifornia91203-
Clinical SiteLong BeachCalifornia90807-
Clinical SitePalm DesertCalifornia92260-
Clinical SitePowayCalifornia92064-
Clinical SiteClearwaterFlorida33761-
Clinical SiteWinter HavenFlorida33880-
Clinical SiteOak ForestIllinois60452-
Clinical SiteSpringfieldIllinois62704-
Clinical SiteHagerstownMaryland21740-
Clinical SiteAlbuquerqueNew Mexico87109-
Clinical SiteChambersburgPennsylvania17201-
Clinical SiteRapid CitySouth Dakota57701-
Clinical SiteGermantownTennessee38138-
Clinical SiteAbileneTexas79606-
Clinical SiteArlingtonTexas76012-
Clinical SiteMcAllenTexas78503-
Clinical SiteSan AntonioTexas78251-
Clinical SiteWillow ParkTexas76087-

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