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

July 16, 2014 updated by: Alcon Research

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AL-39324 Concentration Level A
AL-39324 ophthalmic suspension, single intravitreal injection
Drug: AL-39324 ophthalmic suspension
Experimental: AL-39324 Concentration Level B
AL-39324 ophthalmic suspension, single intravitreal injection
Drug: AL-39324 ophthalmic suspension
Experimental: AL-39324 Concentration Level C
AL-39324 ophthalmic suspension, single intravitreal injection
Drug: AL-39324 ophthalmic suspension
Experimental: AL-39324 Concentration Level D
AL-39324 ophthalmic suspension, single intravitreal injection
Drug: AL-39324 ophthalmic suspension
Experimental: AL-39324 Concentration Level E
AL-39324 ophthalmic suspension, single intravitreal injection
Drug: AL-39324 ophthalmic suspension
Active Comparator: Lucentis
Ranibizumab 10 mg/mL solution, single intravitreal injection
Drug: Ranibizumab 10 mg/mL
Other Names:
  • Lucentis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of targeted adverse events occurring in the study eye
Time Frame: Up to Day 7 after injection
Up to Day 7 after injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in central foveal thickness (CFT) at Month 1
Time Frame: Baseline (Day 0), Month 1
Baseline (Day 0), Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Jennifer M. Kissner, Ph.D., Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

October 8, 2009

First Posted (Estimate)

October 9, 2009

Study Record Updates

Last Update Posted (Estimate)

July 18, 2014

Last Update Submitted That Met QC Criteria

July 16, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-09-023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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