Study of the Safety, Tolerability and Pharmacokinetics of 1 Mg/Eye and 3 Mg/Eye Pegaptanib Sodium in Patients With Exudative Age-Related Macular Degeneration (AMD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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pegaptanib sodium (Macugen)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Other Identifiers

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EOP1006

Identifier Type: -

Identifier Source: org_study_id