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

Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782717
• Other study ID #: C-07-43
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2008
• Last updated: October 22, 2012
• Start date: November 2008
• Est. completion date: July 2010

Study information

• Verified date: October 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Macular Edema
• Retinal Diseases

Intervention

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:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

References & Publications (1)

Singh R, Alpern L, Jaffe GJ, Lehmann RP, Lim J, Reiser HJ, Sall K, Walters T, Sager D. Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy. Clin Ophthalmol. 2012;6:1259-69. doi: 10.2147/O — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery	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).	3 Months	No
Secondary	Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).	BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.	From Day 7 to Day 90 (or Early Exit)	No