Conditions: Macular Edema Diabetic Mellitus Retinal Disease
Keywords: diabetic macular edema Macugen sham-controlled study
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 243
Healthy volunteers: no

Brief summary:
The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.

Detailed description:
During the study, an issue was reported concerning proper maintenance of treatment masking (See Result: Limitations and Caveats)

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: pegaptanib sodium intervention 2: sham injection
Intervention descriptions: intervention 1: Intravitreal injection of 0.3 mg every 6 weeks intervention 2: sham injection every 6 weeks

Protocol document: