The MAKO Study
“A Phase III Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration.” This two-year study is sponsored by Ohr Pharmaceutical and will evaluate patients in two arms: in the first year, (1) those receiving monthly ranibizumab and twice daily Squalamine lactate ophthalmic solution, 0.2%, and (2) those receiving monthly ranibizumab and twice daily placebo ophthalmic solution; in second year, subjects will continue with randomized study medication, and ranibizumab will be administered on a PRN basis – the need for subsequent injections of ranibizumab will be evaluated every 4 weeks (28 ± 7 days) based on OCT-guided retreatment criteria. Subjects who meet inclusion/exclusion criteria at screening/baseline and following confirmation of eligibility from the Central Reading Center will receive an injection of ranibizumab in the eligible study eye. At the Day-0 visit, after the initial ranibizumab injection, subjects will be randomly assigned to either the Squalamine or Placebo arm. Clinic visits for this protocol will occur approximately every 4 weeks, corresponding with the injections, and Primary efficacy assessment will be Week 36. Per the Study Sponsor, screening and enrollment is currently paused as of February 14, 2017.