A Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered from an Episcleral Reservoir for Treatment of Macular Edema Secondary to Diabetes and Other Causes





This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema.



Intervention: Episcleral Dexamethasone Inclusion Criteria • Type I or II diabetes • Age >= 18 years • Visual acuity 20/32 to 20/320 • Macular edema on examination and testing.
Exclusion Criteria • Participation in another clinical trial of non-approved medical treatment within 3 months prior to enrollment • Inability to understand informed consent, cooperate with testing or return to follow up visits • Pregnant or lactating women • Co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.
http://med.stanford.edu/ophthalmology/research/clinical_trials.html


Status: Now accepting new patients PI: Theodore Leng, MD, FACS Research Coordinator: Amy Dennis, amyd05@stanford.edu 650.497.7935 Sponsor: Targeted Therapy Technologies, LLC (3T Ophthalmics) Stanford Investigators: Theodore Leng MD, Steven Sanislo MD, Diana Do MD