NCT00041483

Brief Summary

The purpose of this study is to demonstrate that Anecortave Acetate is as effective after twelve months of treatment as photodynamic therapy (PDT) with Visudyne in patients eligible for initial PDT treatment for wet age-related macular degeneration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
530

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2002

Typical duration for phase_3

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

June 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2002

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 1, 2002

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

July 1, 2014

Status Verified

July 1, 2008

Enrollment Period

3.2 years

First QC Date

July 9, 2002

Last Update Submit

June 30, 2014

Conditions

Macular Degeneration

Keywords

AMDage-related macular degenerationAnecortaveAcetateWet form of age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients Maintaining Vision

    Month 12

Study Arms (2)

Anecortave and Sham PDT

ACTIVE COMPARATOR
Drug: Anecortave Acetate 15 mg sterile suspensionOther: Photodynamic Therapy (PDT)

PDT and Sham Anecortave Acetate

ACTIVE COMPARATOR
Drug: Anecortave Acetate 15 mg sterile suspensionOther: Photodynamic Therapy (PDT)

Interventions

Anecortave Acetate 15 mg sterile suspensionDRUG
Anecortave and Sham PDTPDT and Sham Anecortave Acetate
Photodynamic Therapy (PDT)OTHER
Anecortave and Sham PDTPDT and Sham Anecortave Acetate

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Patients of any race, either gender, aged 50 years and above, diagnosed with subfoveal CNV due to AMD with best corrected logMAR visual acuity of 20/40 (snellen equivalent) to 20/400 (Snellen equivalent) in the study eye. Clinically relevant 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)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

anecortave acetatePhotochemotherapy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2002

First Posted

August 1, 2002

Study Start

June 1, 2002

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

July 1, 2014

Record last verified: 2008-07

Locations

US(1)