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

Part of paid clinical trials in Springfield, Illinois.

Sponsor
Outlook Therapeutics, Inc.
Study ID
NCT05112861
Phase
PHASE3
Status
Active Not Recruiting

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 compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes 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
Nov 9, 2021
Start date
Nov 15, 2021
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Biological: bevacizumab

Primary Outcome Measure

Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or PFS [ Time Frame: 3 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Clinical SiteSpringfieldIllinois62704-
Clinical SiteHagerstownMaryland21740-
Clinical SiteChambersburgPennsylvania17201-

Find similar trials in Springfield, IL

By condition
Age-related macular degenerationDiabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Clinical Site· Springfield, ILClinical Site· Hagerstown, MDClinical Site· Chambersburg, PA

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