NCT Number: NCT00992563
WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination
The purpose of this study is to evaluate the safety, tolerability, and effects of investigational drug AL-39324 for the treatment of wet AMD.
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Conditions
Age range
50 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
About this study
Following a single administration, patients will be followed for 6 months postinjection.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Ranibizumab 10 mg/mL
DrugOther names: Lucentis®
Primary outcomes
-
Incidence of targeted adverse events occurring in the study eye
Time frame: Up to Day 7 after injection
Secondary outcomes
-
Mean change from baseline in central foveal thickness (CFT) at Month 1
Time frame: Baseline (Day 0), Month 1
Sponsors and collaborators
Lead sponsor
Alcon Research
Industry
Registry information
Official study title
A Dose-Escalation Study of AL-39324 Suspension Versus Lucentis® for the Treatment of Exudative Age-Related Macular Degeneration
Important dates
- Study start
- 2010
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Oct 9, 2009
- Registry last updated
- Jul 18, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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