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

NCT ID: NCT00992563

Last Updated: 2014-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-05-31

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.

Conditions

Age Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AL-39324 Concentration Level A

AL-39324 ophthalmic suspension, single intravitreal injection

Group Type: EXPERIMENTAL

AL-39324 ophthalmic suspension

Intervention Type: DRUG

AL-39324 Concentration Level B

AL-39324 ophthalmic suspension, single intravitreal injection

Group Type: EXPERIMENTAL

AL-39324 ophthalmic suspension

Intervention Type: DRUG

AL-39324 Concentration Level C

AL-39324 ophthalmic suspension, single intravitreal injection

Group Type: EXPERIMENTAL

AL-39324 ophthalmic suspension

Intervention Type: DRUG

AL-39324 Concentration Level D

AL-39324 ophthalmic suspension, single intravitreal injection

Group Type: EXPERIMENTAL

AL-39324 ophthalmic suspension

Intervention Type: DRUG

AL-39324 Concentration Level E

AL-39324 ophthalmic suspension, single intravitreal injection

Group Type: EXPERIMENTAL

AL-39324 ophthalmic suspension

Intervention Type: DRUG

Lucentis

Ranibizumab 10 mg/mL solution, single intravitreal injection

Group Type: ACTIVE_COMPARATOR

Ranibizumab 10 mg/mL

Intervention Type: DRUG

Interventions

AL-39324 ophthalmic suspension

Intervention Type: DRUG

Ranibizumab 10 mg/mL

Intervention Type: DRUG

Other Intervention Names

Lucentis®

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer M. Kissner, Ph.D.

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-09-023

Identifier Type: -

Identifier Source: org_study_id