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

Sponsor

Targeted Therapy Technologies, LLC (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04120311

Collaborator

(none)

Enrollment

Location

Arm

12.8

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Macular Edema Radiation Retinopathy Branch Retinal Vein Occlusion Epiretinal Membrane Central Serous Retinopathy With Pit of Optic Disc Commotio Retinae Vitritis	Drug: Episcleral Dexamethasone	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Aug 25, 2020

Anticipated Study Completion Date :

Sep 25, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.