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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03126786
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: IVT aflibercept Drug: Sham SC Drug: SC CLS-TA Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 11, 2017
Actual Primary Completion Date : April 17, 2018
Actual Study Completion Date : April 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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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)]

Drug: SC CLS-TA
SC CLS-TA [40 mg/mL]
Other Name: 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)]

Drug: Sham SC
sham SC


Outcome Measures
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Primary Outcome Measures :
  1. Mean change from baseline in BCVA [ Time Frame: 6 months ]
    Based on ETDRS


Secondary Outcome Measures :
  1. Mean change from baseline in central subfield thickness [ Time Frame: 6 months ]
    Based on spectral domain optical coherence tomography


Eligibility Criteria
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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:

  • 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")
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): NCT03126786


Locations
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Sponsors and Collaborators
Clearside Biomedical, Inc.
Investigators
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Study Director: Thomas Ciulla, MD Clearside Biomedical
More Information
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Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT03126786    
Other Study ID Numbers: CLS1004-201
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Clearside Biomedical, Inc.:
Diabetes Mellitus
Diabetic Retinopathy
Microneedle
Mircoinjection
Triamcinolone
 Choroid
Choroid Injection
Aflibercept
Suprachoroidal
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
 Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action