WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination

This study has been completed.

Sponsor:

Information provided by:

Alcon Research

ClinicalTrials.gov Identifier:

NCT00992563

First received: October 7, 2009

Last updated: July 6, 2011

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 7, 2009
Last Updated Date	July 6, 2011
Start Date ^ICMJE	June 2010
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 8, 2009)	The incidence of targeted adverse events that occur in the study eye within 14 days of the intravitreal injection. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00992563 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 8, 2009)	The mean reduction from baseline of central foveal thickness due to exudative AMD at Month 1. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination
Official Title ^ICMJE	A Dose-Escalation Study of AL-39324 Suspension Versus Lucentis™ for the Treatment of Exudative Age-Related Macular Degeneration
Brief Summary	The purpose of this study is to evaluate the safety, tolerability, and effects of an investigational drug called AL-39324 for the treatment of wet AMD.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Wet AMD
Intervention ^ICMJE	Drug: AL-39324 injectable ophthalmic suspension Drug: Lucentis 10 mg/mL solution for injection
Study Arm (s)	Experimental: 1, AL-39324 AL-39324 in increasing doses of: 0.10, 0.20, 0.30, 0.40 or 0.45 mg Intervention: Drug: AL-39324 Active Comparator: 2, Lucentis ranibizumab 0.5mg Intervention: Drug: Lucentis
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	42
Completion Date	Not Provided
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Must be 50 years of age or older The study eye: must have a primary diagnosis of CNV secondary to AMD lesion must be no larger than 30 mm2 must have edema measuring at least 340 μm must have a visual score between 73 and 34 letters must be able to have clear picture taken of the back of the eye Exclusion Criteria: The study eye must not have been treated for wet AMD previously The study eye must not have any other ocular disease, condition, infection, or recent surgery that would interfere with vision or examination of the back of the eye The study eye must not have uncontrolled glaucoma The study eye must not be missing a lens Must not be taking any medication that is toxic to the lens Must not be taking oral or ocular corticosteroids Must not have an unstable or progressive condition that would interfere with study visits Must not have allergies to any component of the test article or sensitivity to fluorescein dye If female, must not be pregnant or nursing and must agree to adequate birth control Must not be participating in another drug or device study within 30 days of screening for this study
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00992563
Other Study ID Numbers ^ICMJE	C-09-023
Has Data Monitoring Committee	No
Responsible Party	Jennifer M. Kissner, Ph.D., Senior Clinical Trial Manager
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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