Back to resultsWALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination
Primary Purpose
Age Related Macular Degeneration
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AL-39324 ophthalmic suspension
Ranibizumab 10 mg/mL
Sponsored by
About this trial
This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring wet age-related macular degeneration, exudative
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
AL-39324 Concentration Level A
AL-39324 Concentration Level B
AL-39324 Concentration Level C
AL-39324 Concentration Level D
AL-39324 Concentration Level E
Lucentis
Arm Description
AL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 ophthalmic suspension, single intravitreal injection
Ranibizumab 10 mg/mL solution, single intravitreal injection
Outcomes
Primary Outcome Measures
Incidence of targeted adverse events occurring in the study eye
Secondary Outcome Measures
Mean change from baseline in central foveal thickness (CFT) at Month 1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00992563
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
wet age-related macular degeneration, exudative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-39324 Concentration Level A
Arm Type
Experimental
Arm Description
AL-39324 ophthalmic suspension, single intravitreal injection
Arm Title
AL-39324 Concentration Level B
Arm Type
Experimental
Arm Description
AL-39324 ophthalmic suspension, single intravitreal injection
Arm Title
AL-39324 Concentration Level C
Arm Type
Experimental
Arm Description
AL-39324 ophthalmic suspension, single intravitreal injection
Arm Title
AL-39324 Concentration Level D
Arm Type
Experimental
Arm Description
AL-39324 ophthalmic suspension, single intravitreal injection
Arm Title
AL-39324 Concentration Level E
Arm Type
Experimental
Arm Description
AL-39324 ophthalmic suspension, single intravitreal injection
Arm Title
Lucentis
Arm Type
Active Comparator
Arm Description
Ranibizumab 10 mg/mL solution, single intravitreal injection
Intervention Type
Drug
Intervention Name(s)
AL-39324 ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 10 mg/mL
Other Intervention Name(s)
Lucentis®
Primary Outcome Measure Information:
Title
Incidence of targeted adverse events occurring in the study eye
Time Frame
Up to Day 7 after injection
Secondary Outcome Measure Information:
Title
Mean change from baseline in central foveal thickness (CFT) at Month 1
Time Frame
Baseline (Day 0), Month 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer M. Kissner, Ph.D.
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination
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