Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-02-28

Brief Summary

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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 enrolled

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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pegaptanib sodium (Macugen)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients with clinically significant DME, VA 20/50-20/320 in the study eye and 20/100 in the fellow eye

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Other Identifiers

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EOP1005

Identifier Type: -

Identifier Source: org_study_id