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

NCT01157065 | Completed Phase 2 Results

• 1 other identifier: C-09-067
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Exudative Age-Related Macular Degeneration

Keywords

Wet AMD; Intravitreal Injection; Macular Degeneration; VEGF treatment

Outcome Measures

Primary Outcomes (2)

• Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4

  The thickness of the retina was measured using a non-invasive device that produces cross-sectional and 3D images of the eye. The reduction was calculated by subtracting Week 4 visit value from the Baseline value. A positive number indicates a reduction in thickness compared to baseline, whereas a negative number indicates an increase in thickness. An increase in thickness as compared to baseline may indicate a progression of the underlying disease.

  Week 4

• Incidence of Events of Special Interest (ESI)

  An ESI was a protocol-specified event of scientific and medical concern specific to the Sponsor's product or program where ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. These adverse events could have been serious or nonserious and may have required further investigation in order to characterize and understand.

  Up to Day 30

Study Arms (2)

AL-78898A

EXPERIMENTAL

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

Drug: AL-78898A

Lucentis

ACTIVE COMPARATOR

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

Drug: Ranibizumab

Interventions

AL-78898A DRUG

Investigational treatment

AL-78898A

Ranibizumab DRUG

Anti-vascular endothelial growth factor (VEGF) treatment

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 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

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

Results Point of Contact

• Title: Mehdi Hosseini, Clinical Trial Manager
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Mehdi Hosseini

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 2, 2010
• First Posted: July 5, 2010
• Study Start: June 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 4, 2013
• Results First Posted: June 4, 2013

Record last verified: 2013-04

Locations

US (1)