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

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.

Study Overview

• Status: Unknown
• Conditions: Refractory Diabetic Macular Edema
• Intervention / Treatment: Drug: Episcleral Dexamethasone

Detailed Description

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. Numerous studies have documented the anti-inflammatory activity of Dexamethasone in macular edema associated with diabetes, branch retinal vein occlusion, and non-infectious posterior uveitis. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision in patients with diabetic macular edema.

• Study Type: Interventional
• Enrollment (Anticipated): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Recruiting
      • Stanford Medicine Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1; Phase I open label study	Drug: Episcleral Dexamethasone; Sequestered Transscleral, Controlled-Release Dexamethasone; Other Names: Sustained Release Transscleral Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome measure of the study is safety assessment.	The main outcome of the study is safety assessment.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcomes are assessment of visual acuity.	Secondary outcomes are assessment of visual acuity.	12 Months
Secondary outcome are assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).		12 Months

Collaborators and Investigators

• Sponsor: Targeted Therapy Technologies, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2019
• Primary Completion (Anticipated): June 15, 2020
• Study Completion (Anticipated): September 15, 2020

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 28, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: 3TDEX01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No