Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-VEGF Treatment in Patients With Age-Related Macular Degeneration - Tabular View

Tracking Information

First Received Date ^ICMJE

August 2, 2007

Last Updated Date

June 10, 2009

Start Date ^ICMJE

November 2007

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to retreat with ranibizumab [ Time Frame: 1-6 Months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Retreatment Frequency

Change History

Complete list of historical versions of study NCT00511706 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Visual Acuity [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Central Retinal Thickness (OCT) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Lesion size (FA) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Quality of Life questionnaires [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Variability and Frequency of injections, Visual Acuity, Central Retinal Thickness, CNV lesion size and area of leakage, and patient reported outcomes

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-VEGF Treatment in Patients With Age-Related Macular Degeneration

Official Title ^ICMJE

Brief Summary

The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Choroidal Neovascularization
Age-Related Maculopathy

Intervention ^ICMJE

Drug: Dexamethasone and ranibizumab
Other: Sham injection and ranibizumab

Study Arms / Comparison Groups

Experimental: adjunctive therapy of experimental with ranibizumab
Sham Comparator: adjunctive therapy of sham (for masking) and ranibizumab

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

243

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

50 years of age or older with subfoveal CNV (classic and/or occult) secondary to AMD
Visual Acuity between 20/40 and 20/400 in the study eye

Exclusion Criteria:

Any intraocular surgery within 3 months
Glaucoma
Cataract
High eye pressure
Uncontrolled systemic disease

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Israel

Administrative Information

NCT ID ^ICMJE

NCT00511706

Responsible Party

Therapeutic Area Head, Allergan, Inc.

Study ID Numbers ^ICMJE

206207-016

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP