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

Not Recruiting

Trial ID: NCT04120311

Purpose

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 (Ophthalmology Research/Clinical Trials) and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (MSD)

Eligibility

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 (CSF);
* 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.

Intervention(s):

drug: Episcleral Dexamethasone

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amy Dennis, RN
650-497-7935