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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: IVT aflibercept
* Drug: Sham SC
* Drug: SC CLS-TA


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA | Drug: IVT aflibercept<br>* IVT aflibercept [2 mg/0.05 mL]<br>* Other names: Eylea;Drug: SC CLS-TA<br>* CLS-TA [4 mg/100 μL] SC injection<br>* Other names: Triamcinolone Acetonide;|
| Sham Comparator: Control<br>Treatment will consist of IVT aflibercept injection followed by a sham SC procedure | Drug: IVT aflibercept<br>* IVT aflibercept [2 mg/0.05 mL]<br>* Other names: Eylea;Drug: Sham SC<br>* sham SC<br>* Other names: suprachoroidal sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Diabetic Retinopathy, Microneedle, Mircoinjection, Triamcinolone, Choroid, Choroid Injection, Aflibercept, Suprachoroidal, Triamcinolone acetonide