Macular Edema Incidence/Severity Reduction with NEVANAC®
Research type
Research Study
Full title
A Clinical Safety and Efficacy Comparison of NEVANAC® 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients
IRAS ID
22554
Contact name
Michael P. (Mike) Gavin
Contact email
Sponsor organisation
Alcon Research. Ltd
Eudract number
2009-010536-17
Clinicaltrials.gov Identifier
Research summary
Macular oedema (swelling in the back of the eye) most frequently develops within the first 90 days following cataract surgery and occurs at a higher rate in diabetic patients. It usually results in temporary decrease in vision, though may be permanent. Currently, there is no treatment for macular oedema. Study C09003 is designed to investigate whether using an anti-inflammatory eye drop called Nevanac© 0.1% (nepafenac ophthalmic suspension) after cataract surgery may help reduce the chance of people with diabetic retinopathy developing macular oedema. The effect of macular oedema on vision will also be evaluated. Approximately 260 patients (130 per treatment group) age 18 and over will be enrolled at up to 30 sites in Europe and Israel. Patients will administer the study drug (Nevanac© 0.1% or vehicle Ç?ð a substance of no therapeutic value that is used to convey an active medicine for administration) threeðtimesðdaily in the operative eye for 90 days after cataract surgery. Patients will have 9 visits and will be seen for baseline, screening, surgery, Days 1, 7, 14, 30, 60 and 90 unless they are determined to be a treatment failure (inability of a medical therapy to achieve the desired result) and discontinued from the study to begin therapy.
REC name
West of Scotland REC 1
REC reference
10/S0703/12
Date of REC Opinion
6 Apr 2010
REC opinion
Further Information Favourable Opinion