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
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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  
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
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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.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    AL-78898A     Lucentis  
Total, other (not including serious) adverse events      
# participants affected / at risk     14/38     5/11  
Eye disorders      
Conjunctival haemorrhage † 1    
# participants affected / at risk     7/38 (18.42%)     1/11 (9.09%)  
Eye irritation † 1    
# participants affected / at risk     3/38 (7.89%)     0/11 (0.00%)  
Vitreous floaters † 1    
# participants affected / at risk     3/38 (7.89%)     0/11 (0.00%)  
Retinal pigment epithelial tear † 1    
# participants affected / at risk     2/38 (5.26%)     0/11 (0.00%)  
Eye pruritis † 1    
# participants affected / at risk     0/38 (0.00%)     1/11 (9.09%)  
Lens disorder † 1    
# participants affected / at risk     0/38 (0.00%)     1/11 (9.09%)  
Macular degeneration † 1    
# participants affected / at risk     0/38 (0.00%)     1/11 (9.09%)  
Open angle glaucoma † 1    
# participants affected / at risk     0/38 (0.00%)     1/11 (9.09%)  
Infections and infestations      
Nasopharyngitis † 1    
# participants affected / at risk     2/38 (5.26%)     1/11 (9.09%)  
Urinary tract infection † 1    
# participants affected / at risk     1/38 (2.63%)     1/11 (9.09%)  
Psychiatric disorders      
Insomnia † 1    
# participants affected / at risk     3/38 (7.89%)     0/11 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 14.0



  Limitations and Caveats
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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
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