A Multicenter, Randomized, Double-Masked, Controlled Study to Assess the Efficacy and Safety of Ons-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Active Clinical Trials // Aug 28 2019
Sponsor: Outlook Therapeutics, Inc
Principal Investigator: Mihai Mititelu, MD, MPH
Study Coordinator: Nickie Stangel
This study will assess the efficacy and safety of ONS-5010 (an ophthalmic-specific bevacizumab) 1.25 mg intravitreal injections administered monthly compared with ranibizumab 0.5 mg intravitreal injections administered for 3 doses and then quarterly in subjects with primary or recurrent subfoveal choroidal neovascularization (CNV) with or without a classic CNV component secondary to AMD.
Eligible subjects will be randomized in a 1:1 ratio to receive ONS-5010 or ranibizumab. Subjects randomized to receive ONS-5010 will receive 1.25 mg by intravitreal injection every month until Day 330. Subjects randomized to receive ranibizumab will receive 0.5 mg injections in the following manner: injected for 3 doses (Randomization/Day 0, Day 30 and Day 60) followed by 2 further doses every 90 days (Day 150 & Day 240) Note: Subjects in the ranibizumab group will receive sham procedure beginning at Day 90 until Day 300, at visits when they do not receive an active ranibizumab injection.
Diagnosis and Key Eligibility Criteria:
Patients over the age of 50 with visual impairment (approximate Snellen equivalency of 20/50 to 20/320) in the study eye and have active primary or recurrent subfoveal CNV lesions secondary to AMD in the study eye. Treatment naïve patients and patients receiving anti-VEGF treatment for AMD are eligible. If patients with prior anti-VEGF treatment in the study eye are enrolled, a wash out period of 6 weeks from the last injection in the study eye to randomization is required in order to be eligible.
Duration of Study: 12 Months
For more information, contact Nickie Stangel 608-263-8783