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2024-06-30 00:03| 来源: 网络整理| 查看: 265

First Received: October 7, 2009 | Last Updated: July 18, 2014

Phase: Phase 2 | Start Date: June 2010

Overall Status: Completed | Estimated Enrollment: 35

Overview

The purpose of this study is to evaluate the safety, tolerability, and effects of investigational drug AL-39324 for the treatment of wet AMD.

Full Title of Study: “A Dose-Escalation Study of AL-39324 Suspension Versus Lucentis® for the Treatment of Exudative Age-Related Macular Degeneration”

Study Type Study Type: InterventionalStudy DesignAllocation: RandomizedIntervention Model: Parallel AssignmentPrimary Purpose: TreatmentMasking: Double (Participant, Outcomes Assessor)Study Primary Completion Date: May 2011 Detailed Description

Following a single administration, patients will be followed for 6 months postinjection.

Interventions Drug: AL-39324 ophthalmic suspensionDrug: Ranibizumab 10 mg/mL Arms, Groups and Cohorts Experimental: AL-39324 Concentration Level AAL-39324 ophthalmic suspension, single intravitreal injectionExperimental: AL-39324 Concentration Level BAL-39324 ophthalmic suspension, single intravitreal injectionExperimental: AL-39324 Concentration Level CAL-39324 ophthalmic suspension, single intravitreal injectionExperimental: AL-39324 Concentration Level DAL-39324 ophthalmic suspension, single intravitreal injectionExperimental: AL-39324 Concentration Level EAL-39324 ophthalmic suspension, single intravitreal injectionActive Comparator: LucentisRanibizumab 10 mg/mL solution, single intravitreal injection Clinical Trial Outcome Measures Primary MeasuresIncidence of targeted adverse events occurring in the study eyeTime Frame: Up to Day 7 after injectionSecondary MeasuresMean change from baseline in central foveal thickness (CFT) at Month 1Time Frame: Baseline (Day 0), Month 1 Participating in This Clinical Trial 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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details Lead SponsorAlcon ResearchProvider of Information About this Clinical Study SponsorOverall Official(s)Jennifer M. Kissner, Ph.D., Study Director, Alcon Research Conditions in This TrialAge Related Macular Degeneration Additional Key Areas Provided by Investigatorswet age-related macular degeneration, exudative Interventions in This TrialAL-39324 ophthalmic suspensionRanibizumab 10 mg/mL Condition MeSH Term(s)Macular Degeneration Intervention MeSH Term(s)Ranibizumab Information Source

ID Number: C-09-023

NCT Identifier: NCT00992563

Link to the current ClinicalTrials.gov record. – https://clinicaltrials.gov/ct2/show/NCT00992563, June 28, 2024

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

https://trialbulletin.com/lib/entry/ct-00992563

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