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Macular Edema Incidence/Severity Reduction With Nevanac

This study has been terminated.
(Patient recruitment difficulties)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00939276
First received: July 10, 2009
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Retinopathy
 Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)
Drug: Nepafenac ophthalmic suspension vehicle
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Nepafenac
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Percentage of patients who develop macular edema within 90 days following cataract surgery [ Time Frame: Time to event ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in best-corrected visual acuity (BCVA) from baseline to Day 90 [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: August 2009
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NEVANAC
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
 Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)
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
Other Name: NEVANAC®
Placebo Comparator: Nepafenac Vehicle
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
 Drug: Nepafenac ophthalmic suspension vehicle
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939276

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00939276     History of Changes
Other Study ID Numbers: C-09-003, EudraCT Number: 2009-010536-17
Study First Received: July 10, 2009
Last Updated: October 18, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Alcon Research:
cataract surgery
macular edema
prevention

Additional relevant MeSH terms:
Diabetic Retinopathy
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Macular Degeneration
Retinal Degeneration

ClinicalTrials.gov processed this record on May 22, 2013