Anecortave Acetate in Subfoveal Choroidal Neovascularizat... | NCT00051129

Studies
Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (AMD)

NCT00051129

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Nov 28, 2012Estimated

Enrollment

291Actual

Phase

Phase 3

Conditions

Macular Degeneration
Maculopathy, Age-Related
Age-Related Maculopathies
Age-Related Maculopathy
Maculopathies, Age-Related

Interventions

Anecortave Acetate 15 mg sterile suspension
Anecortave Acetate Vehicle

Countries

Not provided

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

Status Module

Record Verification Date

Aug 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

Jan 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Jan 3, 2003

First Submission Date that Met QC Criteria

Jan 6, 2003

First Posted Date

Jan 7, 2003Estimated

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

Nov 27, 2012

Certification/Extension First Submitted that Passed QC Review

Nov 27, 2012

Certification/Extension First Posted Date

Nov 28, 2012Estimated

Last Update Submitted Date

Nov 27, 2012

Last Update Posted Date

Nov 28, 2012Estimated

Description Module

Brief Summary

The purpose of this study was to evaluate anecortave acetate compared to placebo for maintenance of visual acuity after 24 months of treatment in patients with subfovial choroidal neovascularization (CNV) due to exudative age-related macular degeneration (AMD).

Detailed Description

Not provided

Conditions Module

Conditions

Macular Degeneration
Maculopathy, Age-Related
Age-Related Maculopathies
Age-Related Maculopathy
Maculopathies, Age-Related

Keywords

AMD
anecortave acetate
wet AMD
age-related macular degeneration
Macular Degeneration
Maculopathy, Age-Related
Age-Related Maculopathies
Age-Related Maculopathy
Maculopathies, Age-Related

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

291Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anecortave Acetate	Experimental	Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)	Drug: Anecortave Acetate 15 mg sterile suspension
Anecortave Acetate Vehicle	Placebo Comparator	Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)	Other: Anecortave Acetate Vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anecortave Acetate 15 mg sterile suspension	Drug	0.5 ml of 30 mg/ml administered as a posterior juxtascleral injection	Anecortave Acetate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change from baseline in logMAR visual acuity score at 12 months		Month 12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Under 50 years.
Other protocol-defined exclusion criteria may apply.

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

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases