Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema (TYBEE)
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| ClinicalTrials.gov Identifier: NCT03126786 |
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Recruitment Status :
Completed
First Posted : April 24, 2017
Results First Posted : May 13, 2021
Last Update Posted : May 13, 2021
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Sponsor:
Clearside Biomedical, Inc.
Information provided by (Responsible Party):
Clearside Biomedical, Inc.
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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 |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Active
Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA
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Drug: IVT aflibercept
IVT aflibercept [2 mg/0.05 mL]
Other Name: Eylea Drug: SC CLS-TA CLS-TA [4 mg/100 μL] SC injection
Other Name: Triamcinolone Acetonide |
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Sham Comparator: Control
Treatment will consist of IVT aflibercept injection followed by a sham SC procedure
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Drug: IVT aflibercept
IVT aflibercept [2 mg/0.05 mL]
Other Name: Eylea Drug: Sham SC sham SC
Other Name: suprachoroidal sham |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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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")
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
Show 29 study locations
Sponsors and Collaborators
Clearside Biomedical, Inc.
Investigators
| Study Director: | Thomas Ciulla, MD | Clearside Biomedical |
Study Documents (Full-Text)
Documents provided by Clearside Biomedical, Inc.:
Documents provided by Clearside Biomedical, Inc.:
Study Protocol and Statistical Analysis Plan [PDF] January 19, 2018
| Responsible Party: | Clearside Biomedical, Inc. |
| ClinicalTrials.gov Identifier: | NCT03126786 |
| Other Study ID Numbers: |
CLS1004-201 |
| First Posted: | April 24, 2017 Key Record Dates |
| Results First Posted: | May 13, 2021 |
| Last Update Posted: | May 13, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Clearside Biomedical, Inc.:
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Diabetes Mellitus Diabetic Retinopathy Microneedle Mircoinjection Triamcinolone |
Choroid Choroid Injection Aflibercept Suprachoroidal Triamcinolone acetonide |
Additional relevant MeSH terms:
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Macular Edema Edema 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 |