The Purpose of This Study is to Evaluate Efficacy and Safety of NT-101 Eye Drops in Patients With Wet Age-Related Macular Degeneration (AMD)
brief summary
This phase 2 trial is a randomized, double-blind, placebo-controlled, multicenter study in patients with wet AMD to assess the efficacy and safety of NT-101 topical ophthalmic solution (0.20 mM) administered into the study eye twice daily (BID) for 12 weeks.
detailed description
This study will consist of a 4-week screening, 12-week treatment, and 4-week follow-up. After completing screening procedures, approximately 66 eligible subjects will be randomized in a 1:1 ratio to receive 0.20 mM of NT-101 or placebo to be self-administered (or by a caregiver) two drops of NT-101 or placebo into the study eye twice daily for 12 weeks. Following the baseline visit, all study subjects will return to the clinic for study visit assessments at Weeks 4, 8, and 12. Subjects who discontinue early will complete an early termination visit for safety assessments. A follow-up will occur 4 weeks after the end of the treatment period (the last dose) and will include safety and efficacy assessments.
Clinical assessments include BCVA, slit-lamp examination, intraocular pressure (IOP) measurement, optical coherence tomography (OCT), indirect ophthalmoscopy/dilated fundus examination, fundus photography, and fundus fluorescein angiography (FFA). Adverse events (AEs) will be recorded at all study visits.
official title
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of NT-101 Topical Ophthalmic Solution in Patients With Wet Age-Related Macular Degeneration (AMD)