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

Phase 2TerminatedNCT00701181

Quark Pharmaceuticals184 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

184

Conditions

Diabetic Retinopathy Diabetes Complications

Interventions

Laser TreatmentPROCEDURE

Necessity of laser treatment is assessed every three months.

PF-04523655 highDRUG

3 mg intravitreal injection

PF-04523655 middleDRUG

1 mg intravitreal injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (53)

Outcomes

Primary Outcomes

Mean Change from Baseline in the Best Corrected Visual Acuity Score

Time frame: Month 24

Secondary Outcomes

Mean Changes in NEI-VFQ-25 Composite Score from Baseline

Time frame: Month 24, 36

Plasma Concentration of PF-04523655

Time frame: Week 1

Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline.

Time frame: Month 24, 36

Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination

Time frame: Month 24, 36

Mean Change from Baseline in the Best Corrected Visual Acuity Score

Time frame: Month 36

Mean Changes in Area of Fluorescein Leakage from Baseline

Time frame: Month 24, 36

Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from Baseline.

Time frame: Month 24, 36

Mean Changes in Retinal Thickness from Baseline

Time frame: Month 24, 36

Mean Changes in Macular Volume from Baseline

Time frame: Month 24, 36

Data from ClinicalTrials.gov

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