Macular Edema Incidence/Severity Reduction With Nevanac

• Sponsor: Alcon Research (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00939276
• Collaborator: (none)
• Enrollment: 175
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 7.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC®); Drug: Nepafenac ophthalmic suspension vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 175 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Outcome Measures

Primary Outcome Measures

1. Percentage of patients who develop macular edema within 90 days following cataract surgery [Time to event]

Secondary Outcome Measures

1. Mean change in best-corrected visual acuity (BCVA) from baseline to Day 90 [Baseline, Day 90]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center For Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00939276
• Other Study ID Numbers: C-09-003; EudraCT Number: 2009-010536-17
• First Posted: Jul 14, 2009
• Last Update Posted: Oct 23, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Alcon Research: cataract surgery; macular edema; prevention
• Additional relevant MeSH terms: Diabetic Retinopathy; Nepafenac

Study Results

No Results Posted as of Oct 23, 2012