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
Disease Status: diabetic macular edema
Age: 18 years or older
Sponsor: DRCR net
Protocol #: R
Study Duration: 1 year
18 yrs or greater
Type 1 or type 2 Diabetes
Other ophthalmic inclusion that must be met at run in phase.
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.
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
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