NCT01749891

A Safety And Efficacy Study Of ALG-1001 In Human Subjects With Wet Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Allegro Ophthalmics, LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The general objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injections of ALG-1001 in human subjects with wet age-related macular degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema patients.

Detailed description

The general objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injections of ALG-1001 in human subjects with wet age-related macular degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema patients. The specific objective of this six-month study is to evaluate the safety and efficacy of three monthly ophthalmic intravitreal injections of ALG-1001 in human subjects with Wet AMD, and to follow these subjects for an additional four months off-treatment. Three cohorts have been established as part of the study design, utilizing three different doses.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	ALG 1001	Patients who will receive three, monthly intravitreal injections of 1.5mg, 2.5mg ,or 4.0 /50μl of ALG-1001 in 0.05cc in isotonic saline solution.

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-06-04
• Completion: 2013-06-07
• First posted: 2012-12-17
• Last updated: 2017-12-15

Locations

1 site across 1 country: Mexico