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
Results First Received: April 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Exudative Age-Related Macular Degeneration
Interventions: Drug: AL-78898A
Drug: Ranibizumab

  Participant Flow


  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  
Number of Participants  
[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
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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
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Time Frame Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication.
Additional Description An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.

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

Serious Adverse Events
    AL-78898A     Lucentis  
Total, serious adverse events      
# participants affected / at risk     5/38 (13.16%)     1/11 (9.09%)  
General disorders      
Death † 1 [3]    
# participants affected / at risk     0/38 (0.00%)     1/11 (9.09%)  
Injury, poisoning and procedural complications      
Fall † 1 [3]    
# participants affected / at risk     1/38 (2.63%)     0/11 (0.00%)  
Nervous system disorders      
Cerebrovascular Accident † 1 [3]    
# participants affected / at risk     1/38 (2.63%)     0/11 (0.00%)  
Syncope † 1 [3]    
# participants affected / at risk     1/38 (2.63%)     0/11 (0.00%)  
Transient ischaemic attack † 1 [3]    
# participants affected / at risk     2/38 (5.26%)     0/11 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 14.0
[3] Not related




  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Mehdi Hosseini, Clinical Trial Manager
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com


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