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

Phase 1

Active, not recruiting

• Conditions: Macular Edema; Central Serous Retinopathy With Pit of Optic Disc; Commotio Retinae; Epiretinal Membrane; Vitritis; Radiation Retinopathy; Branch Retinal Vein Occlusion
• Interventions: Drug: Episcleral Dexamethasone

• Registration Number: NCT04120311
• Lead Sponsor: Targeted Therapy Technologies, LLC

Brief Summary

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.

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 Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase I open label study	Episcleral Dexamethasone	Drug: Episcleral Dexamethasone Sequestered Transscleral, Controlled-Release Dexamethasone Other Names: • Sustained Release Transscleral Dexamethasone

Primary Outcome Measures

Name	Time	Method
A primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.	12 Months	Assessment of ocular safety as measured by comprehensive ophthalmic exam.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford Medicine Ophthalmology; 🇺🇸 Palo Alto, California, United States