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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
  Purpose

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.


Condition Intervention Phase
Macular Edema
 Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC)
Other: Nepafenac ophthalmic suspension vehicle
Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 263
Study Start Date: November 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
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
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.
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00782717     History of Changes
Other Study ID Numbers: C-07-43
Study First Received: October 29, 2008
Results First Received: August 17, 2011
Last Updated: October 22, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
diabetic retinopathy
cystoid macular edema;

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Cataract
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
 Lens Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013