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
  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
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:
  • Incidence of targeted adverse events occurring in the study eye [ Time Frame: Up to Day 7 after injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean change from baseline in central foveal thickness (CFT) at Month 1 [ Time Frame: Baseline (Day 0), Month 1 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00992563     History of Changes
Other Study ID Numbers: C-09-023
Study First Received: October 7, 2009
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Australia: Human Research Ethics Committee
Israel: Ethics Commission
Switzerland: Ethikkommission
Germany: Ethics Commission
Austria: Ethikkommission
Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 18, 2014