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Trial record 1 of 16 for:    WALTZ
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WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00992563
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE October 7, 2009
First Posted Date  ICMJE October 9, 2009
Last Update Posted Date July 18, 2014
Study Start Date  ICMJE June 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
Incidence of targeted adverse events occurring in the study eye [ Time Frame: Up to Day 7 after injection ]
Original 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
Mean change from baseline in central foveal thickness (CFT) at Month 1 [ Time Frame: Baseline (Day 0), Month 1 ]
Original 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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 investigational drug AL-39324 for the treatment of wet AMD.
Detailed Description Following a single administration, patients will be followed for 6 months postinjection.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Age Related Macular Degeneration
Intervention  ICMJE
  • Drug: AL-39324 ophthalmic suspension
  • Drug: Ranibizumab 10 mg/mL
    Other Name: Lucentis®
Study Arms  ICMJE
  • Experimental: AL-39324 Concentration Level A
    AL-39324 ophthalmic suspension, single intravitreal injection
    Intervention: Drug: AL-39324 ophthalmic suspension
  • Experimental: AL-39324 Concentration Level B
    AL-39324 ophthalmic suspension, single intravitreal injection
    Intervention: Drug: AL-39324 ophthalmic suspension
  • Experimental: AL-39324 Concentration Level C
    AL-39324 ophthalmic suspension, single intravitreal injection
    Intervention: Drug: AL-39324 ophthalmic suspension
  • Experimental: AL-39324 Concentration Level D
    AL-39324 ophthalmic suspension, single intravitreal injection
    Intervention: Drug: AL-39324 ophthalmic suspension
  • Experimental: AL-39324 Concentration Level E
    AL-39324 ophthalmic suspension, single intravitreal injection
    Intervention: Drug: AL-39324 ophthalmic suspension
  • Active Comparator: Lucentis
    Ranibizumab 10 mg/mL solution, single intravitreal injection
    Intervention: Drug: Ranibizumab 10 mg/mL
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
Actual Enrollment  ICMJE
 (submitted: July 16, 2014)
35
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2009)
42
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Willing to give written informed consent, make the required study visits and follow instructions;
  • The study eye:

    • must have a primary diagnosis of choroidal neovascularization (CNV) secondary to AMD;
    • lesion must be no larger than 30 mm2;
    • must have edema measuring greater than 340 μm;
    • must have a visual score between 73 and 34 letters, inclusive;
    • must be able to have clear picture taken of the back of the eye;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • The study eye must not have been treated for exudative 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;
  • Other protocol-defined exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00992563
Other Study ID Numbers  ICMJE C-09-023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Alcon Research
Original Responsible Party Jennifer M. Kissner, Ph.D., Senior Clinical Trial Manager
Current Study Sponsor  ICMJE Alcon Research
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jennifer M. Kissner, Ph.D. Alcon Research
PRS Account Alcon Research
Verification Date July 2014

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