search
Back to results

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
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring cataract surgery, macular edema, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 10, 2009
Last Updated
October 18, 2012
Sponsor
Alcon Research
search

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

Learn more about this trial

Macular Edema Incidence/Severity Reduction With Nevanac

We'll reach out to this number within 24 hrs