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

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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:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2008
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
More Information

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00782717     History of Changes
Other Study ID Numbers: C-07-43
First Posted: October 31, 2008    Key Record Dates
Results First Posted: September 21, 2011
Last Update Posted: October 26, 2012
Last Verified: October 2012

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

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