NCT00701181

Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema

A Phase II Prospective, Randomized, Multi-Center, Diabetic Macular Edema Dose Ranging, Comparator Study Evaluating The Efficacy And Safety Of PF-04523655 Versus Laser Therapy (DEGAS)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Quark Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effectiveness of study drug in improving visual acuity compared to laser treatment in the patients with diabetic macular edema

Detailed description

DEGAS termination decision date was December 17, 2010. Rationale: the objectives of the study could no longer be achieved. The study was not terminated for safety.

Conditions

• Diabetic Retinopathy
• Diabetes Complications

Interventions

Type	Name	Description
PROCEDURE	Laser Treatment	Necessity of laser treatment is assessed every three months.
DRUG	PF-04523655 high	3 mg intravitreal injection
DRUG	PF-04523655 middle	1 mg intravitreal injection
DRUG	PF-04523655 low	0.4 mg intravitreal injection

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2008-06-19
• Last updated: 2012-10-11

Locations

53 sites across 8 countries: United States, Denmark, Germany, India, Israel, Italy, Peru, United Kingdom