NCT00021736

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2001

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2001

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2002

First QC Date

August 3, 2001

Last Update Submit

June 23, 2005

Conditions

Macular DegenerationChoroidal Neovascularization

Keywords

choroidal neovascularization (CNV)subretinal neovascularization

Interventions

EYE001 anti-VEGF aptamerDRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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. Clinically significant concomitant diseases will be excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Foundation for Fighting Blindness

Baltimore, Maryland, United States

Location

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 3, 2001

First Posted

August 6, 2001

Study Start

July 1, 2001

Study Completion

July 1, 2002

Last Updated

June 24, 2005

Record last verified: 2002-07

Locations

US(1)