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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
Enrollment 99
Recruitment Details Subjects were recruited from 14 study centers in the US.
Pre-assignment Details 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.
Arm/Group Title AL-78898A Lucentis
Hide Arm/Group Description Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Period Title: Overall Study
Started 38 11
Completed 38 10
Not Completed 0 1
Reason Not Completed
Death             0             1
Arm/Group Title AL-78898A Lucentis Total
Hide Arm/Group Description Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up Total of all reporting groups
Overall Number of Baseline Participants 38 11 49
Hide Baseline Analysis Population Description
This reporting group includes all randomized subjects who received study medication.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 11 participants 49 participants
18 to 64 years 3 0 3
≥65 years 35 11 46
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 11 participants 49 participants
Female
21
  55.3%
4
  36.4%
25
  51.0%
Male
17
  44.7%
7
  63.6%
24
  49.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants 11 participants 49 participants
38 11 49
1.Primary Outcome
Title Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title AL-78898A Lucentis
Hide Arm/Group Description:
Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Overall Number of Participants Analyzed 24 10
Mean (Standard Deviation)
Unit of Measure: microns
Baseline 514.2  (158) 551.8  (119.0)
Week 4 -12.1  (87.2) 199.9  (139.6)
2.Primary Outcome
Title Incidence of Events of Special Interest (ESI)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received study medication and completed at least one scheduled post-injection study visit
Arm/Group Title AL-78898A Lucentis
Hide Arm/Group Description:
Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Overall Number of Participants Analyzed 38 11
Measure Type: Number
Unit of Measure: events
2 0
Time Frame Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication.
Adverse Event Reporting 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.
 
Arm/Group Title AL-78898A Lucentis
Hide Arm/Group Description Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
All-Cause Mortality
AL-78898A Lucentis
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AL-78898A Lucentis
Affected / at Risk (%) Affected / at Risk (%)
Total   5/38 (13.16%)   1/11 (9.09%) 
General disorders     
Death  1 [1]  0/38 (0.00%)  1/11 (9.09%) 
Injury, poisoning and procedural complications     
Fall  1 [1]  1/38 (2.63%)  0/11 (0.00%) 
Nervous system disorders     
Cerebrovascular Accident  1 [1]  1/38 (2.63%)  0/11 (0.00%) 
Syncope  1 [1]  1/38 (2.63%)  0/11 (0.00%) 
Transient ischaemic attack  1 [1]  2/38 (5.26%)  0/11 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
[1]
Not related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AL-78898A Lucentis
Affected / at Risk (%) Affected / at Risk (%)
Total   14/38 (36.84%)   5/11 (45.45%) 
Eye disorders     
Conjunctival haemorrhage  1  7/38 (18.42%)  1/11 (9.09%) 
Eye irritation  1  3/38 (7.89%)  0/11 (0.00%) 
Vitreous floaters  1  3/38 (7.89%)  0/11 (0.00%) 
Retinal pigment epithelial tear  1  2/38 (5.26%)  0/11 (0.00%) 
Eye pruritis  1  0/38 (0.00%)  1/11 (9.09%) 
Lens disorder  1  0/38 (0.00%)  1/11 (9.09%) 
Macular degeneration  1  0/38 (0.00%)  1/11 (9.09%) 
Open angle glaucoma  1  0/38 (0.00%)  1/11 (9.09%) 
Infections and infestations     
Nasopharyngitis  1  2/38 (5.26%)  1/11 (9.09%) 
Urinary tract infection  1  1/38 (2.63%)  1/11 (9.09%) 
Psychiatric disorders     
Insomnia  1  3/38 (7.89%)  0/11 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title: Mehdi Hosseini, Clinical Trial Manager
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01157065     History of Changes
Other Study ID Numbers: C-09-067
First Submitted: July 2, 2010
First Posted: July 5, 2010
Results First Submitted: April 19, 2013
Results First Posted: June 4, 2013
Last Update Posted: June 4, 2013