A Randomized, Double-Masked, Multi-Center Trial of the Safety, Tolerability and Pharmacokinetics of 1 Mg/Eye and 3 Mg/Eye Intravitreal Injections of Pegaptanib Sodium (Anti-Vegf Pegylated Aptamer) Given Every 6 Weeks for 54 Weeks, in Patients With Exudative Age-Related Macular Degeneration (AMD)

Eyetech Pharmaceuticals0 sites125 target enrollmentNovember 2002

ConditionsAge-Related Macular Degeneration

Drugspegaptanib sodium (Macugen)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Age-Related Macular Degeneration
Sponsor: Eyetech Pharmaceuticals
Enrollment: 125
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The objectives of this study are to characterize the safety, tolerability and pharmacokinetics of pegaptanib when given as 1 or 3mg/eye intravitreous injections every 6 weeks for 54 weeks in patients with subfoveal choroidal neovascularization (CNV) secondary to AMD.

Registry

clinicaltrials.gov

Start Date

November 2002

End Date

May 2006

Last Updated

20 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eyetech Pharmaceuticals

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.
•Subfoveal CNV, secondary to AMD, w/ a total lesion size \[including blood, scar/atrophy \& neovascularization\] of less than or equal to 12 disc areas, of which at least 50% must be active CNV.
•Patients of either sex, aged greater than or equal to 50 years.

Exclusion Criteria

•Previous subfoveal thermal laser therapy. Any subfoveal scarring or atrophy \& no more than 25% of the total lesion size may be made up of scarring or atrophy.
•More than one prior PDT w/ Visudyne is not permitted. Pts may not have rec'd their 1st PDT w/in less than 8 wks or more than 13 wks prior to the BSL angiography/photography for the study.