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

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

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.

Study Overview

• Status: Unknown
• Conditions: Macular Edema; Epiretinal Membrane; Branch Retinal Vein Occlusion; Radiation Retinopathy; Central Serous Retinopathy With Pit of Optic Disc; Commotio Retinae; Vitritis
• 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 macular edema and other disorders of the retina, choroid and vitreous. 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 interface with the pro-inflammatory cascade associated with macular edema due to diabetes, surgery, trauma, vein occlusions, uveitis and retinal degeneration to improve visual structure and function. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision. The investigator's objective is to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Dexamethasone in patients with macular edema; to secondarily assess efficacy in reducing macular edema and improving visual structure and function. The main outcome of the study is safety assessment. Secondary outcomes are assessment of visual acuity and anatomical changes in the macula as measured via optical coherence tomography (OCT) and fluorescein angiogram.

• 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
      • Contact: Amy Dennis, RN; Phone Number: 650-497-7935; Email: amyd05@stanford.edu

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.	Assessment of ocular safety as measured by comprehensive ophthalmic exam.	12 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Targeted Therapy Technologies, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ANTICIPATED): August 25, 2020
• Study Completion (ANTICIPATED): September 25, 2020

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (ACTUAL): October 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Macular Edema; Radiation Retinopathy; Branch Retinal Vein Occlusion; Vitritis; Epiretinal Membrane; Central Serous Retinopathy with Pit of Optic Disc; Commotio Retinae
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Retinal Diseases; Macular Edema; Retinal Vein Occlusion; Edema; Epiretinal Membrane; Central Serous Chorioretinopathy; 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: 3TDEX-02

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