Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration

NCT ID: NCT01157065

Last Updated: 2013-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-04-30

Brief Summary

The primary purpose of this study was to demonstrate a biological effect of AL-78898A, as measured by change (reduction) in central subfield (CSF) retinal thickness 4 weeks after a single intravitreal injection, as compared to LUCENTIS.

Detailed Description

The study consisted of a Screening Visit (Visit 1), a Day 0 visit (Visit 2), 6 on-therapy visits at Day 1, Weeks 1, 2, 3, 4, and 8 (Visits 3-8), and an Exit Visit at Week 12 (Visit 9). Patients who met all inclusion and exclusion criteria at Visit 1 were randomized in a 3:1 ratio to receive either AL-78898A or LUCENTIS as a single 50-μL injection in the study eye. Additionally, patients received standard therapy for exudative AMD beginning at Week 2/Visit 5 if the patient was not improving per protocol-specified criteria. Beginning at Week 4/Visit 7, patients not improving received standard therapy for exudative AMD at the investigator's discretion.

Conditions

Exudative Age-Related Macular Degeneration

Study Design

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

Study Groups

AL-78898A

Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up

Group Type: EXPERIMENTAL

AL-78898A

Intervention Type: DRUG

Investigational treatment

Lucentis

Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up

Group Type: ACTIVE_COMPARATOR

Ranibizumab

Intervention Type: DRUG

Anti-vascular endothelial growth factor (VEGF) treatment

Interventions

AL-78898A

Investigational treatment

Intervention Type: DRUG

Ranibizumab

Anti-vascular endothelial growth factor (VEGF) treatment

Intervention Type: DRUG

Other Intervention Names

LUCENTIS®

Eligibility Criteria

Inclusion Criteria

• Willing to give informed consent, make the required study visits and follow instructions;
• Newly diagnosed with exudative age-related macular degeneration (AMD);
• Presence of primary juxta- or subfoveal choroidal neovascularization (CNV) secondary to AMD (study eye);
• Best-corrected visual acuity (BCVA) in study eye as specified in protocol;
• No vision-threatening ocular condition other than AMD, in the opinion of the Investigator;

Exclusion Criteria

• History or current evidence of macular or retinal disease other than exudative AMD (study eye);
• Any evidence of fibrosis or scarring within the CNV (choroidal neovascularization)lesion (study eye);
• Any evidence of vitreous hemorrhage (study eye);
• History or evidence of surgery (study eye), as specified in protocol;
• Any active systemic infection or ocular/intraocular infection or inflammation in either eye;
• A history or current medical diagnosis of glaucoma or ocular hypertension (study eye), as specified in protocol;
• History or current evidence of a medical condition that may in the opinion of the Investigator preclude the safe administration of test article, adherence to the scheduled study visits, safe participation in the study or affect the results of the study
• History of severe or serious hypersensitivity to any component of the investigational product, reference product or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigator;
• Females of childbearing potential may not participate in the study if pregnant, lactating, or not using adequate birth control methods for the duration of the study;
• Participation in any ocular or non-ocular investigational study within 30 days of screening;
• Has received any approved or investigational therapy for AMD in the study eye with the exception of vitamins;

• 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

Mehdi Hosseini

Role: STUDY_DIRECTOR

Alcon Research

Locations

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

C-09-067

Identifier Type: -

Identifier Source: org_study_id