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

• ClinicalTrials.gov Identifier: NCT00992563
• Recruitment Status: Completed
• First Posted: October 9, 2009
• Last Update Posted: July 18, 2014
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Tracking Information

• First Submitted Date: October 7, 2009
• First Posted Date: October 9, 2009
• Last Update Posted Date: July 18, 2014
• Study Start Date: June 2010
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (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 ]
• Current Secondary Outcome Measures (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 (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: WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Age Related Macular Degeneration

Intervention

• Drug: AL-39324 ophthalmic suspension
• Drug: Ranibizumab 10 mg/mL
  Other Name: Lucentis®

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 16, 2014): 35
• Original Estimated Enrollment (submitted: October 8, 2009): 42
• Actual Study Completion Date: May 2011
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00992563
• Other Study ID Numbers: C-09-023
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Alcon Research
• Original Responsible Party: Jennifer M. Kissner, Ph.D., Senior Clinical Trial Manager
• Current Study Sponsor: Alcon Research
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Jennifer M. Kissner, Ph.D.; Alcon Research

• PRS Account: Alcon Research
• Verification Date: July 2014