NCT00321997

Brief Summary

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.

Trial Health

100
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 May 2001

Longer than P75 for phase_2

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 4, 2006

Status Verified

May 1, 2006

First QC Date

May 2, 2006

Last Update Submit

May 2, 2006

Conditions

Age-Related Macular Degeneration

Keywords

AMDAge-Related Macular DegenerationMacular DegenerationMacugenpegaptanib sodium

Interventions

Pegaptanib sodiumDRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any prior subfoveal thermal laser therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 24997182DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

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

May 2, 2006

First Posted

May 4, 2006

Study Start

May 1, 2001

Study Completion

October 1, 2007

Last Updated

May 4, 2006

Record last verified: 2006-05