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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01157065
Recruitment Status : Completed
First Posted : July 5, 2010
Results First Posted : June 4, 2013
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE July 2, 2010
First Posted Date  ICMJE July 5, 2010
Results First Submitted Date  ICMJE April 19, 2013
Results First Posted Date  ICMJE June 4, 2013
Last Update Posted Date June 4, 2013
Study Start Date  ICMJE June 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
  • Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4 [ Time Frame: 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.
  • Incidence of Events of Special Interest (ESI) [ Time Frame: Up to Day 30 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2010)
Length of time from initiation of study treatment to escape to standard-of-care therapy [ Time Frame: Injection to Week 4 post-injection and beyond up to 40 weeks ]
Change History Complete list of historical versions of study NCT01157065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2010)
  • Mean change in retinal thickness from initiation of study treatment to escape to standard of care therapy [ Time Frame: Injection to Week 4 post-injection and beyond up to 40 weeks ]
  • Mean change in best-corrected visual acuity from initiation of study treatment to escape to standard-of-care therapy [ Time Frame: Injection to Week 4 post-injection and beyond up to 40 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration
Official Title  ICMJE Controlled, Double-Masked, Randomized, Multicenter Study to Evaluate AL-78898A as a Treatment of Exudative AMD
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Exudative Age-Related Macular Degeneration
Intervention  ICMJE
  • Drug: AL-78898A
    Investigational treatment
  • Drug: Ranibizumab
    Anti-vascular endothelial growth factor (VEGF) treatment
    Other Name: LUCENTIS®
Study Arms  ICMJE
  • Experimental: AL-78898A
    Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
    Intervention: Drug: AL-78898A
  • Active Comparator: Lucentis
    Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
    Intervention: Drug: Ranibizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2013)
99
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2010)
110
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01157065
Other Study ID Numbers  ICMJE C-09-067
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mehdi Hosseini Alcon Research
PRS Account Alcon Research
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP