WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination

Age Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992563
• Other study ID #: C-09-023
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2009
• Last updated: July 16, 2014
• Start date: June 2010
• Est. completion date: May 2011

Study information

• Verified date: July 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardAustralia: Human Research Ethics CommitteeIsrael: Ethics CommissionSwitzerland: EthikkommissionGermany: Ethics CommissionAustria: EthikkommissionItaly: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• AL-39324 ophthalmic suspension

• Ranibizumab 10 mg/mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of targeted adverse events occurring in the study eye		Up to Day 7 after injection	Yes
Secondary	Mean change from baseline in central foveal thickness (CFT) at Month 1		Baseline (Day 0), Month 1	No