Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole

NCT04120636 | Unknown Phase 1 DMC FDA Drug

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

Brief Summary

This phase I trial will assess primarily the safety and secondarily the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and other inflammatory disorders of the retina, choroid and vitreous.

Conditions

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

Keywords

Macula 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)

• The primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.

  The primary outcome measure of the study is ocular safety assessment 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 Celecoxib Other Names: * Sequestered, Transscleral, Controlled-Release Celecoxib * Sustained Release Transscleral Celecoxib

Drug: Episcleral Celecoxib

Interventions

Episcleral Celecoxib DRUG

Sustained Release Transscleral Celecoxib

Also known as: Sustained Release Transscleral Celecoxib

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

MeSH Terms

Conditions

Retinal Vein Occlusion; Epiretinal Membrane; Uveitis, Intermediate

Condition Hierarchy (Ancestors)

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

Study Officials

• Theodore Leng, MD

  Stanford Medicine Ophthalmology [Recruiting]

  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 4, 2019
• First Posted: October 9, 2019
• Study Start: March 5, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)