Macular Edema Incidence/Severity Reduction With Nevanac
Information source: Alcon Research
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Retinopathy
Intervention: nepafenac (Nevanac) (Drug); nepafenac (Nevanac) vehicle (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Alcon Research Overall contact:
Alcon Call Center, Phone: 1-888-451-3937
Summary
The purpose of this study is to determine the safety and efficacy of Nevanac for the
prevention of macular edema in patients with diabetic retinopathy within 90 days following
cataract surgery.
Clinical Details
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Primary outcome: percentage of patients who develop macular edema 90 days following surgery
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- NPDR (mild, moderate or severe) in the study eye as defined by the International
Clinical Diabetic Retinopathy Disease Severity Scale
- Central subfield macular thickness < or = 320 micron in the study eye prior to
cataract surgery as determined by SD-OCT and confirmed by the reading center
- Absence of CME or cystoid abnormalities in the study eye as detected by SD-OCT and
confirmed by the reading center
Exclusion Criteria:
- None
Locations and Contacts
Alcon Call Center, Phone: 1-888-451-3937
Contact Alcon Call Center For Trial Locations, Fort Worth, Texas 76134, United States
Additional Information
Starting date: July 2009
Last updated: July 13, 2009
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