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

Phase 2

Terminated

• Conditions: Diabetic Retinopathy; Diabetes Complications
• Interventions: Drug: PF-04523655 high; Drug: PF-04523655 middle; Procedure: Laser Treatment; Drug: PF-04523655 low

• Registration Number: NCT00701181
• Lead Sponsor: Quark Pharmaceuticals

Brief 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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-10
• Disposition First Submitted: 2012-10-09
• Disposition First Submitted QC: 2012-10-09
• Last Update Submitted: 2012-10-09
• Disposition First Posted: 2012-10-11
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• Patients with Diabetes Mellitus (Type 1 or Type 2) Showing Diabetic Macular Edema in the Eye.

Exclusion Criteria

• Proliferative Diabetic Retinopathy in the Study Eye.
• Subjects Receiving Concomitant Intravitreal Anti-VEGF Therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-04523655 (High)	PF-04523655 high	-
PF-04523655 middle	PF-04523655 middle	-
Laser	Laser Treatment	This is a procedure - not a drug intervention.
PF-04523655 low	PF-04523655 low	-

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline in the Best Corrected Visual Acuity Score	Month 24

Secondary Outcome Measures

Name	Time	Method
Mean Changes in NEI-VFQ-25 Composite Score from Baseline	Month 24, 36
Plasma Concentration of PF-04523655	Week 1
Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline.	Month 24, 36
Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination	Month 24, 36
Mean Change from Baseline in the Best Corrected Visual Acuity Score	Month 36
Mean Changes in Area of Fluorescein Leakage from Baseline	Month 24, 36
Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from Baseline.	Month 24, 36
Mean Changes in Retinal Thickness from Baseline	Month 24, 36
Mean Changes in Macular Volume from Baseline	Month 24, 36

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Southampton, United Kingdom