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 ]

Measure Type Primary
Measure Title Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4
Measure Description 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.
Time Frame Week 4  
Safety Issue No  

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.
All patients who received study medication, completed at least one scheduled post-injection study visit, and did not receive standard therapy prior to Week 4 assessment

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

Measured Values
    AL-78898A     Lucentis  
Number of Participants Analyzed  
[units: participants]
  24     10  
Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4  
[units: microns]
Mean ± Standard Deviation
   
Baseline     514.2  ± 158     551.8  ± 119.0  
Week 4     -12.1  ± 87.2     199.9  ± 139.6  

No statistical analysis provided for Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4



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

Measure Type Primary
Measure Title Incidence of Events of Special Interest (ESI)
Measure Description 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.
Time Frame Up to Day 30  
Safety Issue Yes  

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.
Intent-to-treat (ITT): All patients who received study medication and completed at least one scheduled post-injection study visit

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

Measured Values
    AL-78898A     Lucentis  
Number of Participants Analyzed  
[units: participants]
  38     11  
Incidence of Events of Special Interest (ESI)  
[units: events]
  2     0  

No statistical analysis provided for Incidence of Events of Special Interest (ESI)




  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


  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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