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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00992563
First received: October 7, 2009
Last updated: July 16, 2014
Last verified: July 2014

October 7, 2009
July 16, 2014
June 2010
May 2011   (final data collection date for primary outcome measure)
Incidence of targeted adverse events occurring in the study eye [ Time Frame: Up to Day 7 after injection ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00992563 on ClinicalTrials.gov Archive Site
Mean change from baseline in central foveal thickness (CFT) at Month 1 [ Time Frame: Baseline (Day 0), Month 1 ] [ Designated as safety issue: No ]
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 ]
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 investigational drug AL-39324 for the treatment of wet AMD.

Following a single administration, patients will be followed for 6 months postinjection.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Age Related Macular Degeneration
  • Drug: AL-39324 ophthalmic suspension
  • Drug: Ranibizumab 10 mg/mL
    Other Name: Lucentis®
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00992563
C-09-023
No
Alcon Research
Alcon Research
Not Provided
Study Director: Jennifer M. Kissner, Ph.D. Alcon Research
Alcon Research
July 2014

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