WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination
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ClinicalTrials.gov Identifier: NCT00992563 |
Recruitment Status :
Completed
First Posted : October 9, 2009
Last Update Posted : July 18, 2014
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Condition or disease | Intervention/treatment | Phase |
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Age Related Macular Degeneration | Drug: AL-39324 ophthalmic suspension Drug: Ranibizumab 10 mg/mL | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
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 |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: AL-39324 Concentration Level A
AL-39324 ophthalmic suspension, single intravitreal injection
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Drug: AL-39324 ophthalmic suspension |
Experimental: AL-39324 Concentration Level B
AL-39324 ophthalmic suspension, single intravitreal injection
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Drug: AL-39324 ophthalmic suspension |
Experimental: AL-39324 Concentration Level C
AL-39324 ophthalmic suspension, single intravitreal injection
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Drug: AL-39324 ophthalmic suspension |
Experimental: AL-39324 Concentration Level D
AL-39324 ophthalmic suspension, single intravitreal injection
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Drug: AL-39324 ophthalmic suspension |
Experimental: AL-39324 Concentration Level E
AL-39324 ophthalmic suspension, single intravitreal injection
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Drug: AL-39324 ophthalmic suspension |
Active Comparator: Lucentis
Ranibizumab 10 mg/mL solution, single intravitreal injection
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Drug: Ranibizumab 10 mg/mL
Other Name: Lucentis® |
- Incidence of targeted adverse events occurring in the study eye [ Time Frame: Up to Day 7 after injection ]
- Mean change from baseline in central foveal thickness (CFT) at Month 1 [ Time Frame: Baseline (Day 0), Month 1 ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Willing to give written informed consent, make the required study visits and follow instructions;
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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.

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
Study Director: | Jennifer M. Kissner, Ph.D. | Alcon Research |
Responsible Party: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT00992563 |
Other Study ID Numbers: |
C-09-023 |
First Posted: | October 9, 2009 Key Record Dates |
Last Update Posted: | July 18, 2014 |
Last Verified: | July 2014 |
wet age-related macular degeneration, exudative |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |