NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME)
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
This study is being conducted to assess the effects of topical nonsteroidal
anti-inflammatories (NSAIDs) on macular retinal volume compared with placebo in eyes with
non-central diabetic macular edema (DME). A secondary objective of this study is to assess
the effects of topical NSAIDs on central subfield thickness and to compare the progression of
non-central DME to central DME as determined by optical coherence tomography (OCT) and
stereoscopic fundus photographs. Furthermore, this phase II study is being conducted (1) to
determine whether the conduct of a phase III trial has merit based on an anatomic outcome,
(2) to estimate recruitment potential of a phase III investigation, and (3) to provide
information on outcome measures needed to design a phase III trial. The study is not designed
to establish the efficacy of NSAIDs in the treatment of non- central DME.