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

Quark Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Diabetes Complications; Diabetic Retinopathy

Treatments: Procedure: Laser Treatment; Drug: PF-04523655 high; Drug: PF-04523655 low; Drug: PF-04523655 middle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00701181

B0451004

Details and patient eligibility

About

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

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 4 patient groups

Laser

Active Comparator group

Description:

This is a procedure - not a drug intervention.

Treatment:

Procedure: Laser Treatment

PF-04523655 (High)

Experimental group

Treatment:

Drug: PF-04523655 high

PF-04523655 middle

Experimental group

Treatment:

Drug: PF-04523655 middle

PF-04523655 low

Experimental group

Treatment:

Drug: PF-04523655 low