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

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ClinicalTrials.gov Identifier: NCT01157065
Recruitment Status : Completed
First Posted : July 5, 2010
Results First Posted : June 4, 2013
Last Update Posted : June 4, 2013
Sponsor:
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

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


  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

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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  More Information