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

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ClinicalTrials.gov Identifier: NCT04120311

Recruitment Status : Unknown

Verified October 2019 by Targeted Therapy Technologies, LLC.
Recruitment status was: Recruiting

First Posted : October 9, 2019

Last Update Posted : October 9, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Targeted Therapy Technologies, LLC

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

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	September 1, 2019
Estimated Primary Completion Date :	August 25, 2020
Estimated Study Completion Date :	September 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate

Genetic and Rare Diseases Information Center resources: Central Serous Chorioretinopathy Pars Planitis

U.S. FDA Resources

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

Outcome Measures

Primary Outcome Measures :

A primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam. [ Time Frame: 12 Months ]
Assessment of ocular safety as measured by comprehensive ophthalmic exam.

Secondary Outcome Measures :

A secondary outcome is assessment of visual acuity. [ Time Frame: 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). [ Time Frame: 12 Months ]
A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120311

Contacts

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Contact: Amy Dennis	650-497-7935	amyd05@stanford.edu
Contact: Theodore Leng, MD

Locations

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United States, California
Stanford Medicine Ophthalmology	Recruiting
Palo Alto, California, United States, 94303
Contact: Amy Dennis, RN 650-497-7935 amyd05@stanford.edu
Principal Investigator: Theodore Leng, MD

Sponsors and Collaborators

Targeted Therapy Technologies, LLC

Investigators

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Principal Investigator:	Theodore Leng, MD	Stanford Medicine

More Information

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Responsible Party:	Targeted Therapy Technologies, LLC
ClinicalTrials.gov Identifier:	NCT04120311
Other Study ID Numbers:	3TDEX-02
First Posted:	October 9, 2019 Key Record Dates
Last Update Posted:	October 9, 2019
Last Verified:	October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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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

Keywords provided by Targeted Therapy Technologies, LLC:


Macular Edema Radiation Retinopathy Branch Retinal Vein Occlusion Epiretinal Membrane	Central Serous Retinopathy with Pit of Optic Disc Commotio Retinae Vitritis

Additional relevant MeSH terms:

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Macular Edema Retinal Diseases Retinal Vein Occlusion Epiretinal Membrane Central Serous Chorioretinopathy Edema Macular Degeneration Retinal Degeneration Eye Diseases Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Dexamethasone	Dexamethasone acetate BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors

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