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

• 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: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Tracking Information

• First Submitted Date: October 29, 2008
• First Posted Date: October 31, 2008
• Results First Submitted Date: August 17, 2011
• Results First Posted Date: September 21, 2011
• Last Update Posted Date: October 26, 2012
• Study Start Date: November 2008
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 4, 2012)

Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery [ Time Frame: 3 Months ]

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 (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 ]

Current Secondary Outcome Measures (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) ]

BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.

• Original Secondary Outcome Measures (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 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Macular Edema

Intervention

• 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 Arms

• 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 *

• 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.
• Pollack A, Staurenghi G, Sager D, Mukesh B, Reiser H, Singh RP. Prospective randomised clinical trial to evaluate the safety and efficacy of nepafenac 0.1% treatment for the prevention of macular oedema associated with cataract surgery in patients with diabetic retinopathy. Br J Ophthalmol. 2017 Apr;101(4):423-427. doi: 10.1136/bjophthalmol-2016-308617. Epub 2016 Jul 7.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 17, 2011): 263
• Original Estimated Enrollment (submitted: October 29, 2008): 260
• Actual Study Completion Date: July 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00782717
• Other Study ID Numbers: C-07-43
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Alcon Research
• Original Responsible Party: Matt Walker, PhD, Principal Clinical Research Associate
• Current Study Sponsor: Alcon Research
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Alcon Research
• Verification Date: October 2012