NCT00040313

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2002

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2002

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

May 3, 2006

Status Verified

May 1, 2006

First QC Date

June 24, 2002

Last Update Submit

May 2, 2006

Conditions

Diabetic Macular Edema

Interventions

pegaptanib sodium (Macugen)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

pegaptanib
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 24, 2002

First Posted

June 25, 2002

Study Start

October 1, 2002

Study Completion

February 1, 2005

Last Updated

May 3, 2006

Record last verified: 2006-05