CompletedPhase 2/3

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.

United States317 participantsStarted 2005-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year

Timeframe: Baseline, Year 1

Trial details

NCT IDNCT00605280

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-11

Results submitted2010-11-18

View on ClinicalTrials.gov More Macular Edema Associated With Diabetes Mellitus trials