A Phase I Study of Episcleral Dexamethasone for Treatment of Macular Edema

Not Recruiting

Trial ID: NCT04005430

Purpose

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.

Official Title

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

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)

Eligibility

Inclusion Criteria:

* Type I or II diabetes;
* 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 DME, within the central subfield (CSF);
* OCT CSF thickness value (microns):

* Zeiss Cirrus: ≥290 in women; ≥305 in men
* Heidelberg Spectralis: ≥305 in women; ≥320 in men
* Previous treatment with laser, anti-VEGF therapy and/or intravitreal steroids;
* No previous history of glaucoma or steroid-induced intraocular pressure response in either eye.

Exclusion Criteria:

* History of chronic renal failure requiring dialysis or kidney transplant;
* Retinal or optic nerve neovascularization on clinical exam, fundus photographs, or fluorescein angiograms;
* Evidence of external ocular infection;
* History of open-angle glaucoma or intraocular pressure \>= 25 mmHg;
* History of steroid-induced IOP elevation that required IOP-lowering treatment;
* History of prior herpetic ocular infection;
* History of intravitreal or periocular corticosteroids within 3 months prior to enrollment;
* History of macular laser photocoagulation within 4 months prior to enrollment;
* History of antiangiogenic therapy within 4 weeks prior to enrollment;
* History of panretinal photocoagulation (PRP) within 4 months prior to enrollment or anticipated need for PRP in the next 6 months following enrollment;
* Presence of vitreomacular traction, epiretinal membrane, tractional retinal detachment, vitreous hemorrhage and or any ocular condition that the investigator judges could interfere in the safety and efficacy assessments;
* No other major non-diabetic pathology, or anticipation of such in the next 6 months following enrollment that in the opinion of the investigator would substantially and adversely affect assessment of safety and toxicity during the study;
* Participation in another clinical trial of non-approved medical treatment within 3 months prior to enrollment;
* Degenerative myopia;
* Malignant intraocular disease;
* 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
650-497-7935