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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00992563
First Posted: October 9, 2009
Last Update Posted: July 18, 2014
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.
Information provided by (Responsible Party):
Alcon Research
  Purpose
The purpose of this study is to evaluate the safety, tolerability, and effects of investigational drug AL-39324 for the treatment of wet AMD.

Condition Intervention Phase
Age Related Macular Degeneration Drug: AL-39324 ophthalmic suspension Drug: Ranibizumab 10 mg/mL Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:
  • Incidence of targeted adverse events occurring in the study eye [ Time Frame: Up to Day 7 after injection ]

Secondary Outcome Measures:
  • Mean change from baseline in central foveal thickness (CFT) at Month 1 [ Time Frame: Baseline (Day 0), Month 1 ]

Enrollment: 35
Study Start Date: June 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-39324 Concentration Level A
AL-39324 ophthalmic suspension, single intravitreal injection
Drug: AL-39324 ophthalmic suspension
Experimental: AL-39324 Concentration Level B
AL-39324 ophthalmic suspension, single intravitreal injection
Drug: AL-39324 ophthalmic suspension
Experimental: AL-39324 Concentration Level C
AL-39324 ophthalmic suspension, single intravitreal injection
Drug: AL-39324 ophthalmic suspension
Experimental: AL-39324 Concentration Level D
AL-39324 ophthalmic suspension, single intravitreal injection
Drug: AL-39324 ophthalmic suspension
Experimental: AL-39324 Concentration Level E
AL-39324 ophthalmic suspension, single intravitreal injection
Drug: AL-39324 ophthalmic suspension
Active Comparator: Lucentis
Ranibizumab 10 mg/mL solution, single intravitreal injection
Drug: Ranibizumab 10 mg/mL
Other Name: Lucentis®

Detailed Description:
Following a single administration, patients will be followed for 6 months postinjection.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992563


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jennifer M. Kissner, Ph.D. Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00992563     History of Changes
Other Study ID Numbers: C-09-023
First Submitted: October 7, 2009
First Posted: October 9, 2009
Last Update Posted: July 18, 2014
Last Verified: July 2014

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

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents