A Clinical Trial to Explore Safety and Efficacy of Different Doses of Pegaptanib Sodium, Compared to Sham, in Patients With Wet AMD.

May 2, 2006 updated by: Eyetech Pharmaceuticals

A PHASE II/III RANDOMIZED, DOUBLE-MASKED, CONTROLLED, DOSE-RANGING, MULTI-CENTER COMPARATIVE TRIAL, IN PARALLEL GROUPS, TO ESTABLISH THE SAFETY AND EFFICACY OF INTRAVITREAL INJECTIONS OF EYE001 (ANTI-VEGF PEGYLATED APTAMER) GIVEN EVERY 6 WEEKS FOR 54 WEEKS, IN PATIENTS WITH EXUDATIVE AGE-RELATED MACULAR DEGENERATION (AMD)

The purpose of this study is to compare the ability of different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or impriving vision in patients with wet AMD when compared to placebo injections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

540

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects of either gender, aged 50 years or greater. Subfoveal choroidal neovascularization (CNV) due to AMD. Best corrected visual acuity in the study eye between 20/40 and 20/320.

Exclusion Criteria:

Any prior subfoveal thermal laser therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eyetech Pharmaceuticals

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Study Completion

October 1, 2007

Study Registration Dates

First Submitted

May 2, 2006

First Submitted That Met QC Criteria

May 2, 2006

First Posted (Estimate)

May 4, 2006

Study Record Updates

Last Update Posted (Estimate)

May 4, 2006

Last Update Submitted That Met QC Criteria

May 2, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOP1003 and EOP1004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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