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A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00782717
Recruitment Status : Completed
First Posted : October 31, 2008
Results First Posted : September 21, 2011
Last Update Posted : October 26, 2012
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: Prevention
Condition Macular Edema
Interventions Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC)
Other: Nepafenac ophthalmic suspension vehicle
Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)
Enrollment 263
Recruitment Details Patients were recruited from 41 investigative centers from November 2008 to July 2010. 263 patients diagnosed with diabetic retinopathy and requiring cataract extraction with intraocular lens implantation were randomized.
Pre-assignment Details Of the 263 patients enrolled, 12 exited prior to surgery. Baseline characteristics are presented for the ITT population, i.e., patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit.
Arm/Group Title NEVANAC Nepafenac Vehicle
Hide Arm/Group Description One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
Period Title: Overall Study
Started 133 130
Completed 118 102
Not Completed 15 28
Reason Not Completed
Adverse Event             2             5
Patient decision unrelated to AE             6             3
Noncompliance             2             1
Treatment failure             3             14
Enrollment close prior to surgery             1             0
Did not meet entrance criteria             1             3
Exited in error             0             2
Arm/Group Title NEVANAC Nepafenac Vehicle Total
Hide Arm/Group Description One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. Total of all reporting groups
Overall Number of Baseline Participants 125 126 251
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 126 participants 251 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
  36.8%
54
  42.9%
100
  39.8%
>=65 years
79
  63.2%
72
  57.1%
151
  60.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 126 participants 251 participants
Female
83
  66.4%
75
  59.5%
158
  62.9%
Male
42
  33.6%
51
  40.5%
93
  37.1%
1.Primary Outcome
Title Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
Hide Description Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).
Time Frame 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT).
Arm/Group Title NEVANAC Nepafenac Vehicle
Hide Arm/Group Description:
One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
Overall Number of Participants Analyzed 125 126
Measure Type: Number
Unit of Measure: Percentage of patients
3 17
2.Secondary Outcome
Title Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
Hide Description BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.
Time Frame From Day 7 to Day 90 (or Early Exit)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT).
Arm/Group Title NEVANAC Nepafenac Vehicle
Hide Arm/Group Description:
One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
Overall Number of Participants Analyzed 124 122
Measure Type: Number
Unit of Measure: Percentage of patients
6 12
Time Frame Adverse events were collected for the duration of the study: 04 NOV 2008 to 15 JUL 2010.
Adverse Event Reporting Description The safety population included all patients who received exposure or potential exposure to the study drug.
 
Arm/Group Title NEVANAC Nepafenac Vehicle
Hide Arm/Group Description One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
All-Cause Mortality
NEVANAC Nepafenac Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
NEVANAC Nepafenac Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/126 (3.17%)      9/127 (7.09%)    
Cardiac disorders     
Coronary artery disease * 1  1/126 (0.79%)  1 0/127 (0.00%)  0
Cardiac failure congestive * 1  0/126 (0.00%)  0 1/127 (0.79%)  1
Coronary artery occlusion * 1  0/126 (0.00%)  0 1/127 (0.79%)  1
Gastrointestinal disorders     
Pancreatitis * 1  0/126 (0.00%)  0 1/127 (0.79%)  1
General disorders     
Device failure * 1  1/126 (0.79%)  1 0/127 (0.00%)  0
Chest discomfort * 1  0/126 (0.00%)  0 1/127 (0.79%)  1
Chest pain * 1  0/126 (0.00%)  0 1/127 (0.79%)  1
Infections and infestations     
Osteomyelitis * 1  1/126 (0.79%)  1 0/127 (0.00%)  0
Labyrnthitis * 1  0/126 (0.00%)  0 1/127 (0.79%)  1
Injury, poisoning and procedural complications     
Injury * 1  0/126 (0.00%)  0 1/127 (0.79%)  1
Metabolism and nutrition disorders     
Hypoglycaemia * 1  1/126 (0.79%)  1 0/127 (0.00%)  0
Nervous system disorders     
Syncope * 1  0/126 (0.00%)  0 1/127 (0.79%)  1
Renal and urinary disorders     
Renal failure acute * 1  0/126 (0.00%)  0 1/127 (0.79%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  0/126 (0.00%)  0 1/127 (0.79%)  1
Vascular disorders     
Hypertension * 1  0/126 (0.00%)  0 1/127 (0.79%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.4%
NEVANAC Nepafenac Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/126 (7.14%)      19/127 (14.96%)    
Eye disorders     
Eye Pain * 1  1/126 (0.79%)  1 3/127 (2.36%)  3
Eye inflammation * 1  0/126 (0.00%)  0 3/127 (2.36%)  3
Infections and infestations     
Urinary tract infection * 1  0/126 (0.00%)  0 3/127 (2.36%)  3
Injury, poisoning and procedural complications     
Injury * 1  5/126 (3.97%)  5 5/127 (3.94%)  5
Metabolism and nutrition disorders     
Diabetes mellitus * 1  0/126 (0.00%)  0 3/127 (2.36%)  3
Vascular disorders     
Hypertension * 1  3/126 (2.38%)  3 5/127 (3.94%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
[Not Specified]
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 to review study related information prior to presentation or publication
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Alcon Clinical
Organization: Alcon Research, Ltd.
Phone: 888.451.3937 and 817.568.6725
EMail: medinfo@alconlabs.com
Publications of Results:
Singh R, Alpern L, Jaffe GJ, Lehmann RP, Lim J, Reiser HJ, Sall K, Walters T, Sager D. Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy. Clin Ophthalmol. 2012;6:1259-69. doi: 10.2147/OPTH.S31902. Epub 2012 Aug 3.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00782717    
Other Study ID Numbers: C-07-43
First Submitted: October 29, 2008
First Posted: October 31, 2008
Results First Submitted: August 17, 2011
Results First Posted: September 21, 2011
Last Update Posted: October 26, 2012