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

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

pegaptanib sodium (Macugen)

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00040313

First Posted

June 24, 2002

Last Updated

May 2, 2006

Sponsor

Eyetech Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00040313

Brief Title

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

Official Title

A Phase II Randomized, Controlled, Double-Masked, Dose-Finding, Multi-Center, Comparative Trial, in Parallel Groups, to Establish the Safety and Preliminary Efficacy of Intravitreal Injections of EYE001 (Anti-VEGF Pegylated Aptamer), Given Every 6 Weeks for 12 to 30 Weeks to Patients With Clinically Significant Diabetic Macular Edema (CSME) Involving the Center of the Macula

Study Type

Interventional

2. Study Status

Record Verification Date

May 2006

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Eyetech Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

0 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

pegaptanib sodium (Macugen)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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