Phase II/III Study of Anti-VEGF in Neovascular 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

2001-07-31

Study Completion Date

2002-07-31

Brief Summary

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The purpose of the study is to determine whether the anti-VEGF drug is effective at stabilizing and/or improving vision in patients with the wet form of AMD

Detailed Description

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This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center, by percentage of classic CNV vessels: \[predominantly classic (\>50%) vs. minimally classic (1-49%) vs. purely occult (0%)\], and according to whether, or not, they have received prior PDT with Visudyne (no more than once). All patients will be re-randomized after 54 weeks of treatment to either, continue or discontinue therapy for further 48 weeks.

Conditions

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Macular Degeneration Choroidal Neovascularization

Keywords

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choroidal neovascularization (CNV) subretinal neovascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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EYE001 anti-VEGF aptamer

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients of either gender, aged 50 years or above, diagnosed with subfoveal CNV secondary to AMD and with best corrected visual acuity of 20/40 to 20/320 in the absence of subfoveal atrophy or scarring in the study eye, and better or equal to 20/800 in the fellow eye, may be enrolled.

Exclusion Criteria

Clinically significant concomitant diseases will be excluded.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Foundation for Fighting Blindness

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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EOP1004B

Identifier Type: -

Identifier Source: org_study_id