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

NCT00992563 | Completed Phase 2

• 1 other identifier: C-09-023
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Age Related Macular Degeneration

Keywords

wet age-related macular degeneration, exudative

Outcome Measures

Primary Outcomes (1)

• Incidence of targeted adverse events occurring in the study eye

  Up to Day 7 after injection

Secondary Outcomes (1)

• Mean change from baseline in central foveal thickness (CFT) at Month 1

  Baseline (Day 0), Month 1

Study Arms (6)

AL-39324 Concentration Level A

EXPERIMENTAL

AL-39324 ophthalmic suspension, single intravitreal injection

Drug: AL-39324 ophthalmic suspension

AL-39324 Concentration Level B

EXPERIMENTAL

AL-39324 ophthalmic suspension, single intravitreal injection

Drug: AL-39324 ophthalmic suspension

AL-39324 Concentration Level C

EXPERIMENTAL

AL-39324 ophthalmic suspension, single intravitreal injection

Drug: AL-39324 ophthalmic suspension

AL-39324 Concentration Level D

EXPERIMENTAL

AL-39324 ophthalmic suspension, single intravitreal injection

Drug: AL-39324 ophthalmic suspension

AL-39324 Concentration Level E

EXPERIMENTAL

AL-39324 ophthalmic suspension, single intravitreal injection

Drug: AL-39324 ophthalmic suspension

Lucentis

ACTIVE COMPARATOR

Ranibizumab 10 mg/mL solution, single intravitreal injection

Drug: Ranibizumab 10 mg/mL

Interventions

AL-39324 ophthalmic suspension DRUG

AL-39324 Concentration Level A; AL-39324 Concentration Level B; AL-39324 Concentration Level C; AL-39324 Concentration Level D; AL-39324 Concentration Level E

Ranibizumab 10 mg/mL DRUG

Also known as: Lucentis®

Lucentis

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jennifer M. Kissner, Ph.D.

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 9, 2009
• Study Start: June 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 18, 2014

Record last verified: 2014-07