Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Macugen ™ (pegaptanib sodium injection)

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, Age Related Macular Degeneration, Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization

Eligibility Criteria

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

Inclusion Criteria: Best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye. Foveal thickness <= 300 um (measured by OCT center point thickness). Subfoveal choroidal neovascularization secondary to age-related macular degeneration, with a total lesion size (including blood, scar/atrophy & neovascularization) of <= 12 disc areas, of which at least 50% must be active CNV. Exclusion Criteria: Previous subfoveal thermal laser therapy. Any subfoveal atrophy or scarring, blood over the fovea, or fibrosis. Additionally no more than 25% of the total lesion size may be made up of scarring or atrophy. Previous photodynamic therapy with Visudyne (PDT) in the study eye. Eyes with predominantly classic lesions (as classified by fluorescein angiographic appearance) may be enrolled in the trial if, in the clinical judgment of the investigator, PDT can be deferred for at least 54 weeks after the first study treatment

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00087763

First Posted

July 13, 2004

Last Updated

May 2, 2006

Sponsor

Eyetech Pharmaceuticals

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00087763

Brief Title

Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)

Official Title

A Phase II Prospective, Randomized, Double-Masked, Sham-Controlled, Dose-Ranging, Multi-Center Trial to Assess the Effect of Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2006

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Eyetech Pharmaceuticals

Collaborators

Pfizer

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine if Macugen™ reduces foveal thickness and improves vision in patients with wet AMD.

Detailed Description

This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center and foveal thickness to be treated either Macugen or a sham injection. After 24 weeks, all patients will treated with Macugen until the end of the study at 54 weeks.

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, Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

Double

Allocation

Randomized

Enrollment

135 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Macugen ™ (pegaptanib sodium injection)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye. Foveal thickness <= 300 um (measured by OCT center point thickness). Subfoveal choroidal neovascularization secondary to age-related macular degeneration, with a total lesion size (including blood, scar/atrophy & neovascularization) of <= 12 disc areas, of which at least 50% must be active CNV. Exclusion Criteria: Previous subfoveal thermal laser therapy. Any subfoveal atrophy or scarring, blood over the fovea, or fibrosis. Additionally no more than 25% of the total lesion size may be made up of scarring or atrophy. Previous photodynamic therapy with Visudyne (PDT) in the study eye. Eyes with predominantly classic lesions (as classified by fluorescein angiographic appearance) may be enrolled in the trial if, in the clinical judgment of the investigator, PDT can be deferred for at least 54 weeks after the first study treatment

Macular Degeneration

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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