NCT01319487

Safety and Efficacy Study of Topical Administration of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

A 6-month, Phase II, Double-masked, Multicenter, Randomized, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Topical Administration of Two Concentrations of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Fovea Pharmaceuticals SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	2304 Eye Drops High Dose	2304 Eye Drops High Dose self-administered in the study eye during the treatment period
DRUG	2304 Eye Drops Low Dose	2304 Eye Drops Low Dose self-administered in the study eye during the treatment period
DRUG	Placebo Eye Drops	Placebo Eye Drops self-administered in the study eye during the treatment period

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-03-01
• Completion: 2012-06-01
• First posted: 2011-03-21
• Last updated: 2012-08-23

Locations

65 sites across 10 countries: United States, Australia, Belgium, Czechia, France, Germany, Israel, Italy, Poland, Spain