MedDataX Logo

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

NCT ID: NCT04120636

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-05

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phase I open label study

Drug: Episcleral Celecoxib

Other Names:

* Sequestered, Transscleral, Controlled-Release Celecoxib
* Sustained Release Transscleral Celecoxib

Group Type EXPERIMENTAL

Episcleral Celecoxib

Intervention Type DRUG

Sustained Release Transscleral Celecoxib

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Episcleral Celecoxib

Sustained Release Transscleral Celecoxib

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sustained Release Transscleral Celecoxib

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Targeted Therapy Technologies, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Theodore Leng, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Medicine Ophthalmology [Recruiting]

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford Medicine Ophthalmology

Palo Alto, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3TCEL-02

Identifier Type: -

Identifier Source: org_study_id