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

Exudative Age-Related Macular Degeneration Clinical Trial

— RACE  

Official title:

Controlled, Double-Masked, Randomized, Multicenter Study to Evaluate AL-78898A as a Treatment of Exudative AMD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157065
• Other study ID #: C-09-067
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2010
• Last updated: April 19, 2013
• Start date: June 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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;

• Other protocol-specified inclusion criteria may apply.

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;

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exudative Age-Related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• AL-78898A
Investigational treatment
• Ranibizumab
Anti-vascular endothelial growth factor (VEGF) treatment

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes