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. Identifier: NCT01157065
Recruitment Status : Completed
First Posted : July 5, 2010
Results First Posted : June 4, 2013
Last Update Posted : June 4, 2013
Information provided by (Responsible Party):
Alcon Research

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

  Baseline Characteristics

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
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 
[Units: Participants]
Female   21   4   25 
Male   17   7   24 
Region of Enrollment 
[Units: Participants]
United States   38   11   49 

  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