A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients
Information source: Alcon Research
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Edema
Intervention: nepafenac (Drug); Nepafenac vehicle (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Alcon Research Overall contact:
Alcon Call Center, Phone: 1-888-451-3937
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.
Clinical Details
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Primary outcome: percentage of patients who develop macular edema (defined as 30% or greater increase from preoperative baseline in central subfield macular thickness) within 90 days following cataract surgery
Secondary outcome: percentage of patients with best-corrected visual acuity (BCVA) decrease of >5 ETDR letters from the Day 7 postoperative visit
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and
planned cataract extraction by phacoemulsification
Exclusion Criteria:
- central subfiled macular thickness greater than or equal to 250 microns; CME in
either eye
Locations and Contacts
Alcon Call Center, Phone: 1-888-451-3937
Alcon Call Center for Trial Locations, Fort Worth, Texas 76134, United States; Recruiting
Additional Information
Starting date: October 2008
Last updated: September 22, 2009
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