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

NCT04120311 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 3TDEX-02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• A secondary outcome is assessment of visual acuity.

  12 Months

• A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).

  12 Months

Study Arms (1)

Phase I open label study

EXPERIMENTAL

Drug: Episcleral Dexamethasone Sequestered Transscleral, Controlled-Release Dexamethasone Other Names: • Sustained Release Transscleral Dexamethasone

Drug: Episcleral Dexamethasone

Interventions

Episcleral Dexamethasone DRUG

Sustained Release Episcleral Dexamethasone

Also known as: Sequestered Transscleral, Controlled-Release Dexamethasone, Sustained Release Transscleral Dexamethasone

Phase I open label study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Targeted Therapy Technologies, LLC: lead

Study Sites (1)

Stanford Medicine Ophthalmology

Palo Alto, California, 94303, United States

Location

Related Publications (1)

• Romano F, Lamanna F, Gabrielle PH, Teo KYC, Battaglia Parodi M, Iacono P, Fraser-Bell S, Cornish EE, Nassisi M, Viola F, Agarwal A, Samanta A, Chhablani J, Staurenghi G, Invernizzi A. Update on Retinal Vein Occlusion. Asia Pac J Ophthalmol (Phila). 2023 Mar-Apr 01;12(2):196-210. doi: 10.1097/APO.0000000000000598. Epub 2023 Feb 14.

  PMID: 36912792 DERIVED

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion; Epiretinal Membrane; Uveitis, Intermediate

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Uveitis; Uveal Diseases

Study Officials

• Theodore Leng, MD

  Stanford Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 9, 2019
• Study Start: September 1, 2019
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)