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.

Status:	Completed
Conditions:	Cardiology, Ocular, Diabetes
Therapuetic Areas:	Cardiology / Vascular Diseases, Endocrinology, Ophthalmology
Healthy:	No
Age Range:	18 - Any
Updated:	11/18/2018
Start Date:	September 2005
End Date:	July 2011

A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, In Parallel Groups, To Compare The Safety And Efficacy Of Intravitreous Injections Of 0.3 Mg Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks For 2 Years, To Sham Injections In Subjects With Diabetic Macular Edema (DME) Involving The Center Of The Macula With An Open-Label Macugen Year 3 Extension.

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.

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

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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.

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