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

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Diabetic Retinopathy, Diabetes Complications

Intervention / Treatment
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* Procedure: Laser Treatment
* Drug: PF-04523655 high
* Drug: PF-04523655 middle
* Drug: PF-04523655 low


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laser<br>This is a procedure - not a drug intervention. | Procedure: Laser Treatment<br>* Necessity of laser treatment is assessed every three months.<br>|
| Experimental: PF-04523655 (High)<br> | Drug: PF-04523655 high<br>* 3 mg intravitreal injection<br>|
| Experimental: PF-04523655 middle<br> | Drug: PF-04523655 middle<br>* 1 mg intravitreal injection<br>|
| Experimental: PF-04523655 low<br> | Drug: PF-04523655 low<br>* 0.4 mg intravitreal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline in the Best Corrected Visual Acuity Score |  | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Macular Edema, Phase II, Prospective, Randomized, PF-04523655, Laser