A Clinical Trial to Explore Safety and Efficacy of Different Doses of Pegaptanib Sodium, Compared to Sham, in Patients With Wet 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

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2007-10-31

Brief Summary

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The purpose of this study is to compare the ability of different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or impriving vision in patients with wet AMD when compared to placebo injections.

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

Intervention Type DRUG

Eligibility Criteria

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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.

Exclusion Criteria

Any prior subfoveal thermal laser therapy.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

References

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Boyer DS, Goldbaum M, Leys AM, Starita C; V.I.S.I.O.N. Study Group. Effect of pegaptanib sodium 0.3 mg intravitreal injections (Macugen) in intraocular pressure: posthoc analysis from V.I.S.I.O.N. study. Br J Ophthalmol. 2014 Nov;98(11):1543-6. doi: 10.1136/bjophthalmol-2013-304075. Epub 2014 Jul 4.

Reference Type DERIVED

PMID: 24997182 (View on PubMed)

Other Identifiers

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EOP1003 and EOP1004

Identifier Type: -

Identifier Source: org_study_id