NCT00346866

Brief Summary

The purpose of this study was to evaluate the efficacy of anecortave acetate for depot suspension (30 mg and 15 mg) plus PDT versus PDT alone with respect to maintenance of visual acuity in patients with wet AMD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2000

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2006

Completed
Last Updated

August 5, 2008

Status Verified

August 1, 2008

Enrollment Period

1.6 years

First QC Date

June 28, 2006

Last Update Submit

August 4, 2008

Conditions

AMD

Outcome Measures

Primary Outcomes (1)

  • Mean change from the baseline in logMAR visual acuity score at Month 6

Secondary Outcomes (1)

  • % patients who maintained vision, number of months of angiographic evidence of needing PDT re-treatment, and mean lesion sizes for the total choroidal neovascularization (CNV) and the classic component to the total CNV.

Interventions

anecortave acetateDRUG

Eligibility Criteria

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

You may qualify if:

  • AMD disease

You may not qualify if:

  • Age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facility

Beachwood, Ohio, 44122, United States

Location

MeSH Terms

Interventions

anecortave acetate

Study Officials

  • Patricia Zilliox

    Alcon Research

    STUDY DIRECTOR

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

June 28, 2006

First Posted

June 30, 2006

Study Start

May 1, 2000

Primary Completion

December 1, 2001

Study Completion

December 1, 2001

Last Updated

August 5, 2008

Record last verified: 2008-08

Locations

US(1)