Clinical Trials and Research
“SEQUOIA Study: The Safety and Efficacy of Abicipar Pegol in Patients with Neovascular Age-related Macular Degeneration.” The Sequoia study is a Phase 3 study of Abicipar Pegol, sponsored by Allergan, to determine the Safety and Efficacy of Abicipar Pegol in patients with Neovascular Age-related Macular Degeneration. This study will determine change in baseline in BCVA in the study eye, change in baseline in central retinal thickness in the study eye, the percent of patients who gain >15 letters via ETDRS visual acuity testing, and change from baseline, regarding patient responses on National Eye Institute Visual Functioning Questionnaire-25. Sites will randomize two different dosages of abicipar pegol and one dosage of ranibizumab as control, and the treatment administered in different intervals for a total of 96 weeks. The study began in June 2015, screening of patients ended March 17, 2017, and the study will conclude August 2018.
“ILUVIEN Study: A Phase 4 Safety Study of IOP Signals in Patients Treated with ILUVIEN (Fluocinolone Acetonide Intravitreal Implant) 0.19mg.” Patients who are eligible to be part of the PALADIN study are those who are eligible for treatment with Iluvien based on Prescribing Information for Iluvien: it is indicated for the treatment of Diabetic Macular Edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (Iluvien Package Insert, December 2014). This study is sponsored by Alimera Sciences. Excluded patients are those who are unable to understand and sign the Informed Consent Form. Enrollment ended December 31, 2016.
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.
Please contact the Study Coordinator for additional information: Rachel Wilschke 708-484-8500, ext. 427.