Age-Related Macular Degeneration, BRVO - Branch Retinal Vein Occlusion, Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration
Conditions
Brief summary
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.
Interventions
BIOLOGICALbevacizumab
1.25 mg, intravitreal injection
Sponsors
Outlook Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or PFS | 3 months |
Countries
United States
Outcome results
None listed