NCT00040313

CompletedPhase 2

Pegaptanib Sodium Compared to Sham Injection in Patients Wit...

NCT00040313|CompletedPhase 2

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

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

Eyetech Pharmaceuticals

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

EOP1005

Study Type

interventional

Reported enrollment (type unavailable)

0

Locations

0 countries

Sites

N/A

Timeline

Study Start

October 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

February 2005

Date type not reported

This date has not been verified as actual or estimated.

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 0 participants
Study completion date: February 2005
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 24, 2002
Actual (reported)
First Posted
June 25, 2002
Actual (reported)
Study Start
October 2002
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
February 2005
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: May 3, 2006
Status Verified: May 2006
Last Update Submitted: May 2, 2006

Conditions

Diabetic Macular Edema

Interventions

pegaptanib sodium (Macugen)Drug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Eyetech Pharmaceuticals
Industrylead

MeSH Terms

Interventions

pegaptanib

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 2002

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

February 2005

Date type not reported

NCT07870226

Suprachoroidal Triamcinolone Acetonide Monotherapy in Treatment-naive Center Involving Diabetic Macular Edema

Phase 2Not Yet Recruiting

NCT00407381

The Ranibizumab for Edema of the mAcula in Diabetes-2 (READ-2) Study

Phase 2Completed

NCT02511067

Ranibizumab for Edema of the mAcula in Diabetes: Protocol 4 With Tocilizumab: The READ-4 Study

Phase 2Withdrawn

NCT03629210

Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema

Phase 2Withdrawn

NCT00412451

A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)

Phase 2Completed

NCT00284050

Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement

Phase 2Completed

This date has not been verified as actual or estimated.

Last Updated

May 3, 2006

Record last verified: 2006-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00040313
Data provider: ClinicalTrials.gov
Source updated: 2006-05-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:00 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Study Completion

Conditions

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Design

Study Record Dates

Source record