NCT02348359

X-82 to Treat Age-related Macular Degeneration

A Randomized, Double-Masked, Placebo-Controlled, Dose- Finding, Non-Inferiority Study of X-82 Plus Prn Intravitreal (Ivt) Anti-VEGF Compared to Prn Ivt Anti-VEGF Monotherapy in Neovascular AMD

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Tyrogenex · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Age-Related Macular Degeneration (AMD)
• Macular Degeneration
• Exudative Age-related Macular Degeneration
• AMD
• Macular Degeneration, Age-related, 10
• Eye Diseases
• Retinal Degeneration
• Retinal Diseases

Interventions

Type	Name	Description
DRUG	X-82
DRUG	Anti-VEGF
DRUG	Placebo

Timeline

• Start date: 2015-03-16
• Primary completion: 2017-12-12
• Completion: 2018-01-12
• First posted: 2015-01-28
• Last updated: 2022-02-11
• Results posted: 2018-06-27

Locations

35 sites across 1 country: United States