Macular Edema Incidence/Severity Reduction With Nevanac

Diabetic Retinopathy Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00939276
• Other study ID #: C-09-003
• Secondary ID: EudraCT Number:
• Status: Terminated
• Phase: Phase 3
• First received: July 10, 2009
• Last updated: October 18, 2012
• Start date: August 2009
• Est. completion date: August 2011

Study information

• Verified date: October 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 175
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetic Retinopathy

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Contact Alcon Call Center For Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who develop macular edema within 90 days following cataract surgery		Time to event	No
Secondary	Mean change in best-corrected visual acuity (BCVA) from baseline to Day 90		Baseline, Day 90	No