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A Clinical Trial to Explore the Safety and Efficacy of Three Different Doses of Pegaptanib Sodium in Patients With Wet Age-Related Macular Degeneration (AMD)

Primary Purpose

Macular Degeneration

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Pegaptanib sodium

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, Age-Related Macular Degeneration, Macular Degeneration, Macugen, pegaptanib sodium, ERG, specular microscopy, Age-Related Mcular Degeneration (AMD)

Eligibility Criteria

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

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. Normal electroretinogram, and corneal endothelial cell density of 1500 cells/mm2 or more. Exclusion Criteria: Any prior photodynamic therapy (PDT) with Visudyne or thermal laser to the study eye.

Sites / Locations

Charlotte Eye, Ear, Nose and Throat Associates, P.A.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00312351

First Posted

April 6, 2006

Last Updated

January 12, 2007

Sponsor

Eyetech Pharmaceuticals

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00312351

Brief Title

A Clinical Trial to Explore the Safety and Efficacy of Three Different Doses of Pegaptanib Sodium in Patients With Wet Age-Related Macular Degeneration (AMD)

Official Title

An Exploratory Randomized, Double-Masked, Multi-Center Comparative Trial, in Parallel Groups, to Explore the Safety and Efficacy of Three Different Doses of Intravitreous Injections of Pegaptanib Sodium (Anti-VEGF Pegylated Aptamer) Given Every 6 Weeks for 102 Weeks, in Patients With Subfoveal Neovascular Age-Related Macular Degeneration (AMD)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Terminated

Study Start Date

April 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Eyetech Pharmaceuticals

Collaborators

Pfizer

4. Oversight

5. Study Description

Brief Summary

The purpose of this trial is to compare the ability of three different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or improving vision in patients with wet AMD. The study will also examine the effects of pegaptanib sodium on the cornea and sensory retina of patients with wet AMD.

6. Conditions and Keywords

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

Macular Degeneration

Keywords

AMD, Age-Related Macular Degeneration, Macular Degeneration, Macugen, pegaptanib sodium, ERG, specular microscopy, Age-Related Mcular Degeneration (AMD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

262 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Pegaptanib sodium

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Charlotte Eye, Ear, Nose and Throat Associates, P.A.

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial to Explore the Safety and Efficacy of Three Different Doses of Pegaptanib Sodium in Patients With Wet Age-Related Macular Degeneration (AMD)

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