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

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

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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  Show 29 Study Locations

Sponsors and Collaborators

Clearside Biomedical, Inc.

Investigators

Study Director:	Jennifer Kissner, PhD	Vice President, Clinical Development

More Information

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Responsible Party:	Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier:	NCT03126786 History of Changes
Other Study ID Numbers:	CLS1004-201
First Posted:	April 24, 2017
Last Update Posted:	October 4, 2018
Last Verified:	August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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:

Edema; Macular Edema; Signs and Symptoms; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Triamcinolone hexacetonide; Triamcinolone; Triamcinolone Acetonide	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