A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.

Pfizer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Macular Edema Associated With Diabetes Mellitus

Treatments: Drug: Standard of Care; Drug: Macugen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605280

A5751013

EOP1013H

Details and patient eligibility

About

The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.

Enrollment: 317 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• macular edema associated with diabetes
• visual acuity between 20/50 and 20/200

Exclusion criteria

• recent laser therapy in the eye
• recent signs of uncontrolled diabetes
• blood pressure worse than 160/100
• severe cardiac disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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317 participants in 2 patient groups

Sham Control

Sham Comparator group

Treatment:

Drug: Standard of Care

Macugen

Experimental group

Treatment:

Drug: Macugen