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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01157065
First Posted: July 5, 2010
Last Update Posted: June 4, 2013
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.
Information provided by (Responsible Party):
Alcon Research
Results First Submitted: April 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Exudative Age-Related Macular Degeneration
Interventions: Drug: AL-78898A
Drug: Ranibizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from 14 study centers in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 99 subjects enrolled, 48 were considered screen failures and were exited from the study prior to randomization. Of the 51 subjects randomized, 2 did not receive treatment. This reporting group includes all randomized subjects who received study medication.

Reporting Groups
  Description
AL-78898A Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Lucentis Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up

Participant Flow:   Overall Study
    AL-78898A   Lucentis
STARTED   38   11 
COMPLETED   38   10 
NOT COMPLETED   0   1 
Death                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
This reporting group includes all randomized subjects who received study medication.

Reporting Groups
  Description
AL-78898A Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Lucentis Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Total Total of all reporting groups

Baseline Measures
   AL-78898A   Lucentis   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   11   49 
Age, Customized 
[Units: Participants]
     
18 to 64 years   3   0   3 
≥65 years   35   11   46 
Gender 
[Units: Participants]
     
Female   21   4   25 
Male   17   7   24 
Region of Enrollment 
[Units: Participants]
     
United States   38   11   49 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4   [ Time Frame: Week 4 ]

2.  Primary:   Incidence of Events of Special Interest (ESI)   [ Time Frame: Up to Day 30 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information