Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne... | NCT00041483

Studies
Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD

NCT00041483

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Jul 1, 2014Estimated

Enrollment

530Actual

Phase

Phase 3

Conditions

Macular Degeneration

Interventions

Anecortave Acetate 15 mg sterile suspension
Photodynamic Therapy (PDT)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2002

Primary Completion Date

Aug 2005Actual

Completion Date

Aug 2005Actual

First Submitted Date

Jul 9, 2002

First Submission Date that Met QC Criteria

Jul 31, 2002

First Posted Date

Aug 1, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2014

Last Update Posted Date

Jul 1, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

530Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anecortave and Sham PDT	Active Comparator		Drug: Anecortave Acetate 15 mg sterile suspension Other: Photodynamic Therapy (PDT)
PDT and Sham Anecortave Acetate	Active Comparator		Drug: Anecortave Acetate 15 mg sterile suspension Other: Photodynamic Therapy (PDT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anecortave Acetate 15 mg sterile suspension	Drug		Anecortave and Sham PDT PDT and Sham Anecortave Acetate
Photodynamic Therapy (PDT)

Measure	Description	Time Frame
Percentage of Patients Maintaining Vision		Month 12

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Contact Alcon Call Center for Trial Locations		Fort Worth	Texas	76134	United States

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C418047	anecortave acetate
D010778	Photochemotherapy

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy
D010789	Phototherapy

Browse Leaves

Not provided

Browse Branches

Not provided