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

Phase I Study of Sequestered Transscleral, Controlled-Release Celecoxib Delivered Via Episcleral Reservoir for Treatment of Macular Edema & Inflammatory Disorders of the Eye Posterior Pole Including Sclera, Choroid, Retina or Vitreous

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.

Study Overview

• Status: Recruiting
• Conditions: Macula Edema; Epiretinal Membrane; Branch Retinal Vein Occlusion; Radiation Retinopathy; Central Serous Retinopathy With Pit of Optic Disc; Commotio Retinae; Vitritis
• Intervention / Treatment: Drug: Episcleral Celecoxib

Detailed Description

This phase I trial will assess primarily the safety and secondarily anti-inflammatory/neovascular effect of Episcleral Celecoxib in patients suffering from macular edema & inflammatory disorders of the eye posterior pole Including sclera, choroid, retina, or vitreous. Celecoxib is a specific cyclooxygenase-2 inhibitor that possesses anti-angiogenic, anti-inflammatory, and anti-fibrotic properties. Non-clinical studies have documented the activity of Celecoxib in reducing leakage of the blood-retina barrier as well as inhibiting vascular endothelial growth factor (VEGF) and prostaglandin E2 (PGE2) expression in the retina of diabetic rats. The underlying mechanisms for its anti-inflammatory and anti-angiogenic properties have been extensively characterized. The investigators hypothesize that Episcleral Celecoxib is safe, tolerable and that its anti-inflammatory/anti-neovascular activity will reduce macular edema and improve vision in patients with macular edema. Objective: to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Celecoxib in patients with macular edema and other inflammatory disorders of the posterior pole including retina, choroid and vitreous to secondarily assess efficacy in reducing macular edema and improving visual function. Methods: 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).

• Study Type: Interventional
• Enrollment (Anticipated): 3
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Supriya Kawale, RN; Phone Number: 650-497-1481; Email: kawale@stanford.edu
• Study Contact Backup: Name: Theodore Leng, MD; Phone Number: 650-497-1481; Email: kawale@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Recruiting
      • Stanford Medicine Ophthalmology
      • Contact: Supriya Kawale, RN; Phone Number: 650-497-1481; Email: kawale@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase I open label study; Drug: Episcleral Celecoxib Other Names: Sequestered, Transscleral, Controlled-Release Celecoxib; Sustained Release Transscleral Celecoxib	Drug: Episcleral Celecoxib; Sustained Release Transscleral Celecoxib; Other Names: Sustained Release Transscleral Celecoxib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Targeted Therapy Technologies, LLC
• Investigators: Principal Investigator: Theodore Leng, MD, Stanford Medicine Ophthalmology [Recruiting]

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Radiation Retinopathy; Branch Retinal Vein Occlusion; Vitritis; Epiretinal Membrane; Macula Edema; Central Serous Retinopathy with Pit of Optic Disc; Commotio Retinae
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Retinal Diseases; Macular Edema; Retinal Vein Occlusion; Edema; Epiretinal Membrane; Central Serous Chorioretinopathy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: 3TCEL-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No