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

April 22, 2021 updated by: Clearside Biomedical, Inc.

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

The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014-2709
        • Retinal Consultants of Arizona and Retinal Research Institute
      • Tucson, Arizona, United States, 85704
        • Retina Centers, PC
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Beverly Hills, California, United States, 90211-1841
        • Retina Vitreous Medical Group Clinical Research
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates Medical Group, Inc.
      • Palm Desert, California, United States, 92260
        • Retina Institute of California
      • Poway, California, United States, 92064-2526
        • Retina Consultants San Diego
    • Florida
      • Miami, Florida, United States, 33143-5188
        • MedEye Associates
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
      • Sarasota, Florida, United States, 34239
        • Sarasota Retina Institute
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macular Disease
    • Georgia
      • Augusta, Georgia, United States, 30909-6440
        • Emory Eye Center
      • Marietta, Georgia, United States, 30060
        • Marietta Eye Clinic
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Midwest Eye Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Retina and Vitrous Associates of Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Wilmer Eye Institute
      • Hagerstown, Maryland, United States, 21740-5940
        • Cumberland Valley Retina Consultants
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Retina Associates of NJ
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Western Carolina Retinal Associates
    • Oregon
      • Medford, Oregon, United States, 97504
        • Oregon Retina Institute
    • South Dakota
      • Rapid City, South Dakota, United States, 57701-7374
        • Black Hills Regional Eye Institute
    • Texas
      • Abilene, Texas, United States, 79606-1224
        • Retina Research Institute of Texas
      • Arlington, Texas, United States, 76012-2505
        • Texas Retina Associates-Arlington
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute, P.A.
      • San Antonio, Texas, United States, 78240-1502
        • Medical Center Ophthalmology Associates
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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")

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Active
Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA
Drug: IVT aflibercept
IVT aflibercept [2 mg/0.05 mL]
Other Names:
  • Eylea
Drug: SC CLS-TA
CLS-TA [4 mg/100 μL] SC injection
Other Names:
  • Triamcinolone Acetonide
SHAM_COMPARATOR: Control
Treatment will consist of IVT aflibercept injection followed by a sham SC procedure
Drug: IVT aflibercept
IVT aflibercept [2 mg/0.05 mL]
Other Names:
  • Eylea
Drug: Sham SC
sham SC
Other Names:
  • suprachoroidal sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Best Corrected Visual Acuity Letter Score
Time Frame: Baseline, 6 months
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.
Baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Central Subfield Thickness
Time Frame: Baseline, 6 months
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.
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clearside Biomedical, Inc.

Investigators

  • Study Director: Thomas Ciulla, MD, Clearside Biomedical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 11, 2017

Primary Completion (ACTUAL)

April 17, 2018

Study Completion (ACTUAL)

April 17, 2018

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (ACTUAL)

April 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS1004-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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