Macular Edema Incidence/Severity Reduction With Nevanac

Phase 3

Terminated

• Conditions: Diabetic Retinopathy
• Interventions: Drug: Nepafenac ophthalmic suspension vehicle; Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)

• Registration Number: NCT00939276
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-13
• Study First Posted: 2009-07-14
• Study Start: 2009-08
• Primary Completion: 2011-05
• Study Completion: 2011-08
• Disposition First Submitted: 2012-09-27
• Disposition First Submitted QC: 2012-09-27
• Status Verified: 2012-10
• Disposition First Posted: 2012-10-01
• Last Update Submitted: 2012-10-18
• Last Update Posted: 2012-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 175

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nepafenac Vehicle	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
NEVANAC	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

Primary Outcome Measures

Name	Time	Method
Percentage of patients who develop macular edema within 90 days following cataract surgery	Time to event

Secondary Outcome Measures

Name	Time	Method
Mean change in best-corrected visual acuity (BCVA) from baseline to Day 90	Baseline, Day 90

Trial Locations

Locations (1)

Contact Alcon Call Center For Trial Locations; 🇺🇸 Fort Worth, Texas, United States