NexThera Co., Ltd.
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.
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…
Inclusion Criteria: 1. Subject who is male or female ≥ 50 years of age at Screening. 2. CNV lesions secondary to AMD that affect the central subfield in the study eye that meet the following criteria at Screening: * CNV lesions affect the fovea, as evidenced by fluorescein angiography in study eye. * Intraretinal and/or subretinal fluid affecting the central subfield visible on OCT. If fluid is not visible due to previous treatment, earlier documented OCT images showing fluid for diagnosing wet AMD can be reviewed to fulfill this criterion. 3. BCVA between 35 and 78 letters, inclusive,…
NT-101 is a topical ophthalmic solution containing pigment epithelium-derived factor (PEDF) 34 and type I atelocollagen
NT-101 without Drug Substance
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