X-82 to Treat Age-related Macular Degeneration

Macular Degeneration Clinical Trial

Official title: 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

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). ;

Related Conditions & MeSH terms

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

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