Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula
The purpose of the study is to determine whether pegaptanib sodium (Macugen) is safe and
effective in slowing the leakage of fluid within the retina and thereby stabilizing or
improving vision when compared to placebo injections. A total of 176 patients will be
Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug,
MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not
been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may
slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the
The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a
“pretend” injection. In addition, the purpose of this study is to measure the action of the
study drug in the body over a period of time and to check for the presence of the study drug
in your blood (called pharmacokinetics or PK).
This study will involve approximately 90 people. People who decide to participate will have
an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™
and one of which is a “pretend” injection.
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