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Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema (TYBEE)

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IVT aflibercept
Sham SC
SC CLS-TA
Sponsored by
Clearside Biomedical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetes Mellitus, Diabetic Retinopathy, Microneedle, Mircoinjection, Triamcinolone, Choroid, Choroid Injection, Aflibercept, Suprachoroidal, Triamcinolone acetonide

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of type 1 or type 2 DM
  • DME with central involvement (> 300 µm in the central subfield on spectral-domain optical coherence tomography [SD-OCT], in the study eye
  • ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye
  • Naïve to local pharmacologic treatment for DME in the study eye

Exclusion Criteria:

  • IOP > 21 mmHg in the study eye at Visit 1 (Day -30 to -1); subjects are not excluded if IOP is <22 mmHg in the study eye with no more than 1 IOP lowering medication
  • Any previous treatment in the study eye with an ocular corticosteroid implant
  • Has significant media opacity precluding evaluation of retina and vitreous in the study eye.
  • History of glaucoma or optic nerve head change consistent with glaucoma damage
  • History of glaucoma surgery
  • History of clinically significant IOP elevation in response to corticosteroid treatment ("steroid responder")

Sites / Locations

  • Retinal Consultants of Arizona and Retinal Research Institute
  • Retina Centers, PC
  • California Retina Consultants
  • Retina Vitreous Medical Group Clinical Research
  • Northern California Retina Vitreous Associates Medical Group, Inc.
  • Retina Institute of California
  • Retina Consultants San Diego
  • MedEye Associates
  • Retina Specialty Institute
  • Sarasota Retina Institute
  • Center for Retina and Macular Disease
  • Emory Eye Center
  • Marietta Eye Clinic
  • Midwest Eye Institute
  • Retina and Vitrous Associates of Kentucky
  • The Johns Hopkins Wilmer Eye Institute
  • Cumberland Valley Retina Consultants
  • Retina Associates of NJ
  • Western Carolina Retinal Associates
  • Oregon Retina Institute
  • Black Hills Regional Eye Institute
  • Retina Research Institute of Texas
  • Texas Retina Associates-Arlington
  • Austin Retina Associates
  • Texas Retina Associates
  • Valley Retina Institute, P.A.
  • Valley Retina Institute
  • Medical Center Ophthalmology Associates
  • Retina Consultants of Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active

Control

Arm Description

Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA

Treatment will consist of IVT aflibercept injection followed by a sham SC procedure

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Best Corrected Visual Acuity Letter Score
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.

Secondary Outcome Measures

Mean Change From Baseline in Central Subfield Thickness
Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.

Full Information

First Posted
April 20, 2017
Last Updated
April 22, 2021
Sponsor
Clearside Biomedical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03126786
Brief Title
Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema
Acronym
TYBEE
Official Title
Randomized, Double Masked, Controlled Study Comparing the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
April 17, 2018 (Actual)
Study Completion Date
April 17, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.
Detailed Description
This is a Phase 2, multicenter, randomized, double-masked, controlled, parallel-group study of 6 months duration in treatment-naïve subjects with DME. This study is projected to enroll approximately 60 subjects, randomly assigned 1:1 to one of two treatment groups. The study design includes up to 8 clinic visits over approximately 24 weeks. Subjects will attend visits for Screening (Visit 1, Days -30 to 0); Randomization and Baseline (Visit 2, Day 0 before dosing); Dosing and Evaluation (Visit 2 after dosing to Visit 5, Day 0 through Week 12); As-needed (PRN) Dosing and Follow up (Visit 6 through Visit 7, Week 16 through Week 20), and End of Study (Visit 8, Week 24).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetes Mellitus, Diabetic Retinopathy, Microneedle, Mircoinjection, Triamcinolone, Choroid, Choroid Injection, Aflibercept, Suprachoroidal, Triamcinolone acetonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Description
Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Treatment will consist of IVT aflibercept injection followed by a sham SC procedure
Intervention Type
Drug
Intervention Name(s)
IVT aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
IVT aflibercept [2 mg/0.05 mL]
Intervention Type
Drug
Intervention Name(s)
Sham SC
Other Intervention Name(s)
suprachoroidal sham
Intervention Description
sham SC
Intervention Type
Drug
Intervention Name(s)
SC CLS-TA
Other Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
CLS-TA [4 mg/100 μL] SC injection
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Best Corrected Visual Acuity Letter Score
Description
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Central Subfield Thickness
Description
Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of type 1 or type 2 DM DME with central involvement (> 300 µm in the central subfield on spectral-domain optical coherence tomography [SD-OCT], in the study eye ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye Naïve to local pharmacologic treatment for DME in the study eye Exclusion Criteria: IOP > 21 mmHg in the study eye at Visit 1 (Day -30 to -1); subjects are not excluded if IOP is <22 mmHg in the study eye with no more than 1 IOP lowering medication Any previous treatment in the study eye with an ocular corticosteroid implant Has significant media opacity precluding evaluation of retina and vitreous in the study eye. History of glaucoma or optic nerve head change consistent with glaucoma damage History of glaucoma surgery History of clinically significant IOP elevation in response to corticosteroid treatment ("steroid responder")
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Ciulla, MD
Organizational Affiliation
Clearside Biomedical
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Consultants of Arizona and Retinal Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014-2709
Country
United States
Facility Name
Retina Centers, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Retina Vitreous Medical Group Clinical Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211-1841
Country
United States
Facility Name
Northern California Retina Vitreous Associates Medical Group, Inc.
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Retina Institute of California
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Retina Consultants San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064-2526
Country
United States
Facility Name
MedEye Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143-5188
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Emory Eye Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909-6440
Country
United States
Facility Name
Marietta Eye Clinic
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Retina and Vitrous Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
The Johns Hopkins Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740-5940
Country
United States
Facility Name
Retina Associates of NJ
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Western Carolina Retinal Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Oregon Retina Institute
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701-7374
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606-1224
Country
United States
Facility Name
Texas Retina Associates-Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012-2505
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Valley Retina Institute, P.A.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240-1502
Country
United States
Facility Name
Retina Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema

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