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Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole


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Trial ID: NCT04120311


This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.

Official Title

Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered Via Episcleral Reservoir for Treatment of Macular Edema & Inflammatory Disorders of the Eye Posterior Pole Including Sclera, Choroid, Retina or Vitreous

Stanford Investigator(s)

Theodore Leng, MD, FACS
Theodore Leng, MD, FACS

Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)


Inclusion Criteria:

   - Age >= 18 years;

   - Visual acuity letter score in study eye < 70 and ≥ 25 letters (approximate Snellen
   equivalent 20/32 to 20/320);

   - Ophthalmoscopic evidence of center-involved macular edema, within the central subfield

   - Inflammatory disorders of the sclera, choroid, retina or vitreous

Exclusion Criteria:

   - 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.


drug: Episcleral Dexamethasone


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amy Dennis, RN