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
  Purpose

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.


Condition Intervention Phase
Wet AMD
Drug: AL-39324
Drug: Lucentis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose-Escalation Study of AL-39324 Suspension Versus Lucentis™ for the Treatment of Exudative Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 42
Study Start Date: June 2010
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1, AL-39324
AL-39324 in increasing doses of: 0.10, 0.20, 0.30, 0.40 or 0.45 mg
Drug: AL-39324
injectable ophthalmic suspension
Active Comparator: 2, Lucentis
ranibizumab 0.5mg
Drug: Lucentis
10 mg/mL solution for injection

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992563

Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Jennifer M. Kissner, Ph.D., Senior Clinical Trial Manager
ClinicalTrials.gov Identifier: NCT00992563     History of Changes
Other Study ID Numbers: C-09-023
Study First Received: October 7, 2009
Last Updated: July 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
wet age-related macular degeneration, exudative

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014