NCT00134667

Brief Summary

The purpose of the trial is to compare whether Macugen (pegaptanib sodium) in combination with PDT with Visudyne (verteporfin) is safe and effective in slowing down the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to Macugen alone. Patients must be recently diagnosed with predominantly classic wet AMD and must be eligible for PDT.

Trial Health

57
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Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

January 15, 2007

Status Verified

January 1, 2007

First QC Date

August 24, 2005

Last Update Submit

January 12, 2007

Conditions

Age-Related Macular Degeneration

Keywords

AMDAge-Related Macular DegenerationMacular DegenerationMacugenPhotodynamic TherapyPDTVisudynepegaptanib sodiumverteporfinPredominantly ClassicAge-Related Macular Degeneration (AMD)

Interventions

Photodynamic Therapy (PDT) with Visudyne (verteporfin)DRUG
Macugen (pegaptanib sodium)DRUG

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 with predominantly classic lesion composition
  • Best corrected visual acuity in the study eye between 20/40 and 20/200

You may not qualify if:

  • Any prior PDT with Visudyne to the study eye
  • Any previous AMD thermal laser therapy to the study eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Centers, P.C., Northwest Location

Tucson, Arizona, 85704-5614, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Photochemotherapy1-phenyl-3,3-dimethyltriazeneVerteporfinpegaptanib

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapyPorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 25, 2005

Study Start

March 1, 2005

Study Completion

October 1, 2008

Last Updated

January 15, 2007

Record last verified: 2007-01

Locations

US(1)