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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01157065
First received: July 2, 2010
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Exudative Age-Related Macular Degeneration
Drug: AL-78898A
Drug: Ranibizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Controlled, Double-Masked, Randomized, Multicenter Study to Evaluate AL-78898A as a Treatment of Exudative AMD

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Incidence of Events of Special Interest (ESI) [ Time Frame: Up to Day 30 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 99
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-78898A
Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Drug: AL-78898A
Investigational treatment
Active Comparator: Lucentis
Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Drug: Ranibizumab
Anti-vascular endothelial growth factor (VEGF) treatment
Other Name: 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157065

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Mehdi Hosseini Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01157065     History of Changes
Other Study ID Numbers: C-09-067
Study First Received: July 2, 2010
Results First Received: April 19, 2013
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Wet AMD
Intravitreal Injection
Macular Degeneration
VEGF treatment

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 31, 2014