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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04120636
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Targeted Therapy Technologies, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Macula Edema Radiation Retinopathy Branch Retinal Vein Occlusion Epiretinal Membrane Central Serous Retinopathy With Pit of Optic Disc Commotio Retinae Vitritis Drug: Episcleral Celecoxib Phase 1

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 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 Celecoxib 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 18, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Celecoxib

Arms and Interventions
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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 Name: Sustained Release Transscleral Celecoxib


Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam. [ Time Frame: 12 Months ]
    The primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.


Secondary Outcome Measures :
  1. A secondary outcome is assessment of visual acuity. [ Time Frame: 12 Months ]
    A secondary outcome is assessment of visual acuity.

  2. 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
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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
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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): NCT04120636


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

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   
Contact: Theodore Leng, MD         
Sponsors and Collaborators
Targeted Therapy Technologies, LLC
Investigators
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Principal Investigator: Theodore Leng, MD Stanford Medicine Ophthalmology [Recruiting]
More Information
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Responsible Party: Targeted Therapy Technologies, LLC
ClinicalTrials.gov Identifier: NCT04120636    
Other Study ID Numbers: 3TCEL-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
Keywords provided by Targeted Therapy Technologies, LLC:
Macula 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
 Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action