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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00992563

Enrollment

Registered

2009-10-09

Start date

2010-06-30

Completion date

2011-05-31

Last updated

2014-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Macular Degeneration

Keywords

wet age-related macular degeneration, exudative

Brief 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.

Detailed description

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

Interventions

DRUGAL-39324 ophthalmic suspension

DRUGRanibizumab 10 mg/mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026