Language: BG BG
← Back to results
Active (not recruiting) Phase 3 NCT05112861

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

Phase 3 – large-scale trial before approval
Conditions: Age-Related Macular Degeneration Neovascular Age-related Macular Degeneration Wet Macular Degeneration BRVO - Branch Retinal Vein Occlusion Diabetic Macular Edema

Sponsor: Outlook Therapeutics, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * Active clinical diagnosis and OCT confirmation of one of the following retinal disorders: exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or branch retinal vein occlusion (BRVO) and, in the opinion of the Investigator, requires treatment with an anti-VEGF therapy Exclusion Criteria: * Previous use of approved anti-VEGF or Avastin® within 4 weeks preceding randomization * Previous use of Beovu® * Macular edema due to something other than exudative AMD, DME or BRVO, in the study eye * History of inadequate response to previous intravitreal anti-VEGF therapy * History of any intraocular or periocular corticosteroid injection or implant, in the study eye * Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization * Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss during the study period * Active intraocular inflammation in the study eye * Current vitreous hemorrhage in the study eye * Polypoidal choroidal vasculopathy (PCV) in the study eye * History of idiopathic, infectious or autoimmune-associated uveitis in either eye * Current ocular or periocular infection, such as conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication) * Premenopausal women not using adequate contraception * Current treatment for active systemic infection * Known allergy to any component of the study drug , not amenable to treatment
Interventions
bevacizumab
BIOLOGICAL
Locations 3
United States (3)
Clinical Site
Chambersburg , Pennsylvania
Clinical Site
Hagerstown , Maryland
Clinical Site
Springfield , Illinois
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.11.2021
Completion date
01.12.2027
Registry ID
NCT05112861
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.