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Clinical Trial 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.


Clinical Trial Description

Subjects will be randomized in a 1:1:1:1 ratio to the following dose groups: - X-82 50 mg plus ivt anti-VEGF prn - X-82 100 mg plus ivt anti-VEGF prn - X-82 200 mg plus ivt anti-VEGF prn - Placebo plus ivt anti-VEGF prn Subjects will be treated for a total of 52 weeks with one of three doses of X-82 or placebo. Primary Efficacy Outcome: The primary efficacy outcome is the change in visual acuity score from Day -1 to 52 Weeks after randomization. Safety Outcomes: Systemic and ocular safety will be evaluate by assessing ECG, laboratory analyses, adverse events and serious adverse events. Approximately 132 subjects will be randomized into one of the four arms (33 subjects per dose group). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02348359
Study type Interventional
Source Tyrogenex
Contact
Status Terminated
Phase Phase 2
Start date March 16, 2015
Completion date January 12, 2018

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