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Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

Primary Purpose

Uveitis, Intermediate Uveitis, Posterior Uveitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
triamcinolone acetonide (Triesence®)
Sponsored by
Clearside Biomedical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis focused on measuring uveitis, intermediate uveitis, posterior uveitis, panuveitis, noninfectious uveitis, microneedle, suprachoroidal space, SCS, inflammation, ocular inflammatory conditions, triamcinolone acetonide, TA, Triesence, injection, IVT, intravitreal, corticosteroid, sympathetic ophthalmia, temporal arteritis, vitreous haze

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of non-infectious intermediate, posterior or pan-uveitis

Exclusion Criteria:

  • any ocular trauma within the past 6 months in the study eye
  • any injection of intraocular corticosteroids or steroid implant or the Ozurdex® implant in the 6 months prior to the study treatment, or any prior use of Retisert™ in the study eye
  • any uncontrolled systemic disease that would preclude participation in the study or put the subject at risk due to study treatment or procedures
  • have a known HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated
  • are monocular
  • have ocular hypertension
  • history of any intraocular surgery in the study eye
  • presence of an anterior staphyloma in the study eye

Sites / Locations

  • Northwestern University
  • University of Nebraska Medical Center
  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

triamcinolone acetonide (Triesence®)

Arm Description

TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)

Outcomes

Primary Outcome Measures

Change in Intraocular Pressure (IOP)
Intraocular pressure is the fluid pressure inside the eye. Intraocular pressure change from baseline at week 8 was measured by Goldmann applanation tonometry. Tonometry is the method eye care professionals use to determine this pressure. Intraocular pressure is typically measured in millimeters of mercury. A higher pressure inside the eye can be a risk factor for developing glaucoma or glaucoma progression leading to optic nerve damage. A negative change indicates a reduction in intraocular pressure.
Best Corrected Visual Acuity
Visual acuity (VA) rates a person's ability to recognize small details with precision. Best corrected VA refers to this measurement when the best vision has be achieved following refraction. Visual acuity change from baseline at 8 and 26 weeks was measured following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol using standardized lighting and lanes and an ETDRS eye chart. This eye chart comprises rows of letters, with 5 letters per row, and with the letter size from line to line varying logarithmically and is used to estimate visual acuity. Visual acuity is scored with reference to the logarithm of the minimum angle of resolution or logMAR. Zero logMAR indicates standard vision, positive values indicate poor vision and negative values indicate good vision. A negative changes indicates an improvement in visual acuity.

Secondary Outcome Measures

Central Subfield Thickness Using Optical Coherence Tomography (OCT)
Central subfield thickness (CST) is a measure of the thickness of the retina in the 1 mm diameter circle centered on the fovea or center of the macular where eyesight is the sharpest. CST change from baseline at 8 and 26 weeks was measured using optical coherence tomography (OCT). OCT is a diagnostic imaging technique used to capture 2 and 3 dimensional images within biological tissue, e.g., for determining the amount of edema contained in the retina. CST is typically measured in microns. A negative change represents a reduction in retinal thickness and an improvement in cases of retinal edema.
Vitreous Haze Grade
Vitreous haze scale (Nussenblatt 1985 as modified in Lowder 2011). Scores include value 0 (no inflammation), +0.5 (trace inflammation), +1 (mild blurring of the retinal vessels and optic nerve), +1.5 (optic nerve head and posterior retina view obscuration greater than +1 but less than +2), +2 (moderate blurring of the optic nerve head), +3 (marked blurring of the optic nerve head), and +4 (optic nerve head not visible) A higher score indicates a worse outcome.

Full Information

First Posted
February 5, 2013
Last Updated
February 17, 2021
Sponsor
Clearside Biomedical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01789320
Brief Title
Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis
Official Title
Open-Label, Safety and Tolerability Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle in Subjects With Non-Infectious Uveitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clearside Biomedical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to determine the safety and tolerability of a single microinjection of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have non-infectious uveitis.
Detailed Description
This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability and procedure of a microneedle injection of triamcinolone acetonide (TA) into the SCS. The subjects enrolled in this study will be chosen from subjects with non-infectious intermediate, posterior and pan-uveitis. The injection will only be administered to a single eye via the Clearside Biomedical proprietary microneedle into the SCS. The dose of TA to be injected is 4 mg of currently approved TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL). The study design includes 10 clinic visits over 27 weeks. Subjects will be followed for 26 weeks following treatment with TRIESENCE®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis, Noninfectious Uveitis
Keywords
uveitis, intermediate uveitis, posterior uveitis, panuveitis, noninfectious uveitis, microneedle, suprachoroidal space, SCS, inflammation, ocular inflammatory conditions, triamcinolone acetonide, TA, Triesence, injection, IVT, intravitreal, corticosteroid, sympathetic ophthalmia, temporal arteritis, vitreous haze

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
triamcinolone acetonide (Triesence®)
Arm Type
Experimental
Arm Description
TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide (Triesence®)
Other Intervention Name(s)
triamcinolone acetonide, TA, Triesence, corticosteroid
Intervention Description
4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Primary Outcome Measure Information:
Title
Change in Intraocular Pressure (IOP)
Description
Intraocular pressure is the fluid pressure inside the eye. Intraocular pressure change from baseline at week 8 was measured by Goldmann applanation tonometry. Tonometry is the method eye care professionals use to determine this pressure. Intraocular pressure is typically measured in millimeters of mercury. A higher pressure inside the eye can be a risk factor for developing glaucoma or glaucoma progression leading to optic nerve damage. A negative change indicates a reduction in intraocular pressure.
Time Frame
Change from baseline in IOP at 8 weeks
Title
Best Corrected Visual Acuity
Description
Visual acuity (VA) rates a person's ability to recognize small details with precision. Best corrected VA refers to this measurement when the best vision has be achieved following refraction. Visual acuity change from baseline at 8 and 26 weeks was measured following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol using standardized lighting and lanes and an ETDRS eye chart. This eye chart comprises rows of letters, with 5 letters per row, and with the letter size from line to line varying logarithmically and is used to estimate visual acuity. Visual acuity is scored with reference to the logarithm of the minimum angle of resolution or logMAR. Zero logMAR indicates standard vision, positive values indicate poor vision and negative values indicate good vision. A negative changes indicates an improvement in visual acuity.
Time Frame
Change from baseline at 8 weeks and 26 weeks.
Secondary Outcome Measure Information:
Title
Central Subfield Thickness Using Optical Coherence Tomography (OCT)
Description
Central subfield thickness (CST) is a measure of the thickness of the retina in the 1 mm diameter circle centered on the fovea or center of the macular where eyesight is the sharpest. CST change from baseline at 8 and 26 weeks was measured using optical coherence tomography (OCT). OCT is a diagnostic imaging technique used to capture 2 and 3 dimensional images within biological tissue, e.g., for determining the amount of edema contained in the retina. CST is typically measured in microns. A negative change represents a reduction in retinal thickness and an improvement in cases of retinal edema.
Time Frame
Change from baseline at 8 weeks and 26 weeks.
Title
Vitreous Haze Grade
Description
Vitreous haze scale (Nussenblatt 1985 as modified in Lowder 2011). Scores include value 0 (no inflammation), +0.5 (trace inflammation), +1 (mild blurring of the retinal vessels and optic nerve), +1.5 (optic nerve head and posterior retina view obscuration greater than +1 but less than +2), +2 (moderate blurring of the optic nerve head), +3 (marked blurring of the optic nerve head), and +4 (optic nerve head not visible) A higher score indicates a worse outcome.
Time Frame
Change from baseline at 8 weeks and 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of non-infectious intermediate, posterior or pan-uveitis Exclusion Criteria: any ocular trauma within the past 6 months in the study eye any injection of intraocular corticosteroids or steroid implant or the Ozurdex® implant in the 6 months prior to the study treatment, or any prior use of Retisert™ in the study eye any uncontrolled systemic disease that would preclude participation in the study or put the subject at risk due to study treatment or procedures have a known HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated are monocular have ocular hypertension history of any intraocular surgery in the study eye presence of an anterior staphyloma in the study eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Ciulla, MD
Organizational Affiliation
Clearside Biomedical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27980877
Citation
Goldstein DA, Do D, Noronha G, Kissner JM, Srivastava SK, Nguyen QD. Suprachoroidal Corticosteroid Administration: A Novel Route for Local Treatment of Noninfectious Uveitis. Transl Vis Sci Technol. 2016 Dec 14;5(6):14. doi: 10.1167/tvst.5.6.14. eCollection 2016 Dec.
Results Reference
derived

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Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

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