X-82 to Treat Age-related Macular Degeneration

• Status: Terminated
• Trial end date: 2018-01-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tyrogenex
• Collaborators: International Drug Development Institute; SynteractHCR, Inc
• Treatments: Aflibercept; Bevacizumab; Ranibizumab

Criteria

Inclusion Criteria:

• Participants mush have wet AMD which has been diagnosed and treated with anti-VEGF in one or both eyes for at least 6 months prior to joining the study and has required at least two prior injections of intravitreal (ivt) anti-VEGF at intervals of not greater than 6 weeks for the past two injections in the eye that is selected to be the study eye.

• Must have demonstrated a reduction in macular fluid or macular thickness in the study eye 14 days following an anti-VEGF injection at Screening Visit 1

• Early Treatment Diabetic Retinopathy (ETDRS) Best Corrected Visual Acuity (BCVA) of 25 letters (20/320) or better in both eyes

Exclusion Criteria:

• Previous vitrectomy to the study eye within 30 days of Screening Visit 1

• Choroidal neovascularization (CNV) due to causes other than AMD

• Proliferative diabetic retinopathy in either eye