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OpenTrials
Completed

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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Key information

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

AL-39324 ophthalmic suspension

Drug

Ranibizumab 10 mg/mL

Drug

Other names: Lucentis®

Primary outcomes

  1. Incidence of targeted adverse events occurring in the study eye

    Time frame: Up to Day 7 after injection

Secondary outcomes

  1. 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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