Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-08-31

Brief Summary

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To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.

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Detailed Description

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Conditions

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Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active

Group Type EXPERIMENTAL

pegaptanib sodium (Macugen)

Intervention Type DRUG

0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.

Interventions

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pegaptanib sodium (Macugen)

0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.

Intervention Type DRUG

Other Intervention Names

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MACUGEN

Eligibility Criteria

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Inclusion Criteria

* Clinical and angiographic evidence of juxtafoveal or subfoveal choroidal neovascularization secondary to AMD with a total lesion size of less than 2 MPS disc areas
* Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS)
* Women must be using 2 forms of effective contraception
* Adequate hematological, renal and liver functions

Exclusion Criteria

* Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area
* Any extrafoveal choroidal neovascularization
* Any intraocular surgery or thermal laser to the study eye within 3 months of enrollment
* Previous or concomitant therapy for AMD including PDT with verteporfin (Visudyne) or subfoveal/non-foveal thermal laser therapy, transpupillary thermotherapy, external beam radiation, submacular surgery.
* Presence of other causes of choroidal neovascularization, including pathological myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No