Study Detail: DRCR R

Trial Description Summary
A Phase II multi – center double masked randomized study to assess the effects of topical NSAID, Nepafenac 0.1%, 3 times a day on macular retinal volume compared with placebo in eyes with non-central DME. 

Basic Trial Information
Phase: II 
Disease Status: diabetic macular edema
Age: 18 years or older 
Sponsor: DRCR net
Protocol #: R
Status: Enrolling
Study Duration: 1 year  

Eligibility Criteria
Inclusion Criteria
      18 yrs or greater
      Type 1 or type 2 Diabetes
      Other ophthalmic inclusion that must be met at run in phase.
Exclusion Criteria
OPHTHAMLIC EXCLUSION: STUDY EYE ONLY:
      History of focal/grid laser within the last 6mo or other treatment for DME within the last 4 months. 
      Anticipate need to treat DME during the course of the study.
      History of using NSAID eye drops within the last 30 days, or anticipate need for such drops.
      History of PRP within 4 months prior to randomization or anticipated to be needed next 6months 
      Lipid in center of macula
      History of major ocular surgery within prior 4 months or anticipated in the next 6 months
      Anticipate need for cataract surgery during study period.
      History of cataract removal within prior 1 year or YAG within 2 months prior to randomization.
      History of vitrectomy for any reason.
      Uncontrolled glaucoma.
      An ocular condition other than diabetic macular edema

GENERAL MEDICAL EXCLUSION
     Unstable Blood pressure (>180/110), cardiovascular disease, glycemic control
     Systemic corticosteroids or anti-VEGF therapy
     Auto-immune diseases which may increase patient risk of corneal complications.
     Pregnant, intending to get pregnant, or lactating.

Other inclusion/exclusion criteria per protocol to be screened by the Clinical Coordinator

Study Title
A Phase II Evaluation of Topical NSAIDs in Eyes with Non Central Involved DME

Trial Contact Information
Site: Study Coordinator Larraine Stone
   216/831-5704 ext. 253