Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT02348359
Brief 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.
Detailed 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:
NCT02348359
Study Brief:
Protocol Section:
NCT02348359