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

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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

Tracking Information
First Submitted Date  ICMJE October 4, 2019
First Posted Date  ICMJE October 9, 2019
Last Update Posted Date October 9, 2019
Actual Study Start Date  ICMJE September 18, 2019
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
  • A secondary outcome is assessment of visual acuity. [ Time Frame: 12 Months ]
    A secondary outcome is assessment of visual acuity.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Macula Edema
  • Radiation Retinopathy
  • Branch Retinal Vein Occlusion
  • Epiretinal Membrane
  • Central Serous Retinopathy With Pit of Optic Disc
  • Commotio Retinae
  • Vitritis
Intervention  ICMJE Drug: Episcleral Celecoxib
Sustained Release Transscleral Celecoxib
Other Name: Sustained Release Transscleral Celecoxib
Study Arms  ICMJE Experimental: Phase I open label study

Drug: Episcleral Celecoxib

Other Names:

  • Sequestered, Transscleral, Controlled-Release Celecoxib
  • Sustained Release Transscleral Celecoxib
Intervention: Drug: Episcleral Celecoxib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2019)
3
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amy Dennis, RN 650-497-7935 amyd05@stanford.edu
Contact: Theodore Leng, MD 650-497-7935 amyd05@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04120636
Other Study ID Numbers  ICMJE 3TCEL-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Targeted Therapy Technologies, LLC
Study Sponsor  ICMJE Targeted Therapy Technologies, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Theodore Leng, MD Stanford Medicine Ophthalmology [Recruiting]
PRS Account Targeted Therapy Technologies, LLC
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP