Macular Edema Incidence/Severity Reduction With Nevanac
Primary Purpose
Diabetic Retinopathy
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)
Nepafenac ophthalmic suspension vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring cataract surgery, macular edema, prevention
Eligibility Criteria
Inclusion Criteria:
- Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens (IOL) into the lens capsule.
- History of Type 1 or Type 2 diabetes.
- History of nonproliferative diabetic retinopathy (NPDR), mild, moderate, or severe, in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale.
- Able to understand and sign an informed consent approved by an IRB/IEC.
- Central subfield macular thickness less than or equal to 320 μm in the study eye prior to cataract surgery.
- Absence of clinically significant macular edema in the study eye as detected by clinical exam.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by the reading center or Investigator.
- Current or previous ocular disease other than diabetic retinopathy in the study eye that, in the opinion of the Investigator, would have confounded the assessments of the macula, the retina, or central vision.
- Planned multiple procedures for the study eye during the cataract/IOL implantation surgery (eg, trabeculoplasty, corneal transplant).
- Corneal transplant in study eye.
- Baseline cumulative corneal fluorescein staining score (ie, sum of scores for all 5 corneal regions) for the study eye greater than or equal to 5, or baseline corneal fluorescein staining score in any single region for the study eye greater than or equal to 3.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Contact Alcon Call Center For Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NEVANAC
Nepafenac Vehicle
Arm Description
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Outcomes
Primary Outcome Measures
Percentage of patients who develop macular edema within 90 days following cataract surgery
Secondary Outcome Measures
Mean change in best-corrected visual acuity (BCVA) from baseline to Day 90
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00939276
Brief Title
Macular Edema Incidence/Severity Reduction With Nevanac
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Patient recruitment difficulties
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate NEVANAC in patients with diabetic retinopathy who developed macular edema (ME) within 90 days following cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
cataract surgery, macular edema, prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NEVANAC
Arm Type
Experimental
Arm Description
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Arm Title
Nepafenac Vehicle
Arm Type
Placebo Comparator
Arm Description
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Intervention Type
Drug
Intervention Name(s)
Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)
Other Intervention Name(s)
NEVANAC®
Intervention Description
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Intervention Type
Drug
Intervention Name(s)
Nepafenac ophthalmic suspension vehicle
Intervention Description
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Primary Outcome Measure Information:
Title
Percentage of patients who develop macular edema within 90 days following cataract surgery
Time Frame
Time to event
Secondary Outcome Measure Information:
Title
Mean change in best-corrected visual acuity (BCVA) from baseline to Day 90
Time Frame
Baseline, Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens (IOL) into the lens capsule.
History of Type 1 or Type 2 diabetes.
History of nonproliferative diabetic retinopathy (NPDR), mild, moderate, or severe, in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale.
Able to understand and sign an informed consent approved by an IRB/IEC.
Central subfield macular thickness less than or equal to 320 μm in the study eye prior to cataract surgery.
Absence of clinically significant macular edema in the study eye as detected by clinical exam.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by the reading center or Investigator.
Current or previous ocular disease other than diabetic retinopathy in the study eye that, in the opinion of the Investigator, would have confounded the assessments of the macula, the retina, or central vision.
Planned multiple procedures for the study eye during the cataract/IOL implantation surgery (eg, trabeculoplasty, corneal transplant).
Corneal transplant in study eye.
Baseline cumulative corneal fluorescein staining score (ie, sum of scores for all 5 corneal regions) for the study eye greater than or equal to 5, or baseline corneal fluorescein staining score in any single region for the study eye greater than or equal to 3.
Other protocol-defined exclusion criteria may apply.
Facility Information:
Facility Name
Contact Alcon Call Center For Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27388251
Citation
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.
Results Reference
derived
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Macular Edema Incidence/Severity Reduction With Nevanac
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