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

Alcon

Status and phase: Completed; Phase 2

Conditions: Age Related Macular Degeneration

Treatments: Drug: AL-39324 ophthalmic suspension; Drug: Ranibizumab 10 mg/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00992563

C-09-023

Details and patient eligibility

About

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

Full description

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

Enrollment: 35 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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 exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 6 patient groups

AL-39324 Concentration Level A

Experimental group

Description:

AL-39324 ophthalmic suspension, single intravitreal injection

Treatment:

Drug: AL-39324 ophthalmic suspension

AL-39324 Concentration Level B

Experimental group

Description:

AL-39324 ophthalmic suspension, single intravitreal injection

Treatment:

Drug: AL-39324 ophthalmic suspension

AL-39324 Concentration Level C

Experimental group

Description:

AL-39324 ophthalmic suspension, single intravitreal injection

Treatment:

Drug: AL-39324 ophthalmic suspension

AL-39324 Concentration Level D

Experimental group

Description:

AL-39324 ophthalmic suspension, single intravitreal injection

Treatment:

Drug: AL-39324 ophthalmic suspension

AL-39324 Concentration Level E

Experimental group

Description:

AL-39324 ophthalmic suspension, single intravitreal injection

Treatment:

Drug: AL-39324 ophthalmic suspension

Lucentis

Active Comparator group

Description:

Ranibizumab 10 mg/mL solution, single intravitreal injection

Treatment:

Drug: Ranibizumab 10 mg/mL