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

October 7, 2009
July 6, 2011
June 2010
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00992563 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination
A Dose-Escalation Study of AL-39324 Suspension Versus Lucentis™ for the Treatment of Exudative Age-Related Macular Degeneration

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Wet AMD
  • Drug: AL-39324
    injectable ophthalmic suspension
  • Drug: Lucentis
    10 mg/mL solution for injection
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
Not Provided
June 2011   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00992563
C-09-023
No
Jennifer M. Kissner, Ph.D., Senior Clinical Trial Manager
Alcon Research
Not Provided
Not Provided
Alcon Research
July 2011

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