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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00782717

First received: October 29, 2008

Last updated: October 22, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 29, 2008
Last Updated Date	October 22, 2012
Start Date ^ICMJE	November 2008
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 4, 2012)	Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery [ Time Frame: 3 Months ] [ Designated as safety issue: No ] 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).
Original Primary Outcome Measures ^ICMJE (submitted: October 29, 2008)	percentage of patients who develop macular edema (defined as 30% or greater increase from preoperative baseline in central subfield macular thickness) within 90 days following cataract surgery [ Time Frame: preoperative baseline and postoperative days 7, 14, 30, 60, 90 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00782717 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 4, 2012)	Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA). [ Time Frame: From Day 7 to Day 90 (or Early Exit) ] [ Designated as safety issue: No ] BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.
Original Secondary Outcome Measures ^ICMJE (submitted: October 29, 2008)	percentage of patients with best-corrected visual acuity (BCVA) decrease of >5 ETDR letters from the Day 7 postoperative visit [ Time Frame: preoperative baseline and postoperative days 7, 14, 30, 60, 90 ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients
Official Title ^ICMJE	A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients
Brief Summary	The purpose of this study is to determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Macular Edema
Intervention ^ICMJE	Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC) 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery. Other Name: NEVANAC Other: Nepafenac ophthalmic suspension vehicle 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED) One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery. Other Name: OMNIPRED
Study Arm (s)	Experimental: NEVANAC 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. Interventions: Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC) Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED) Placebo Comparator: Nepafenac Vehicle 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. Interventions: Other: Nepafenac ophthalmic suspension vehicle Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	263
Completion Date	July 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Central subfiled macular thickness greater than or equal to 250 microns CME in either eye. Other protocol-defined exclusion criteria may apply.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00782717
Other Study ID Numbers ^ICMJE	C-07-43
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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