Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

Study Overview
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Brief Summary
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This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.

Detailed Description
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A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion

Official Title
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SAPPHIRE: A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Conjunction With Intravitreal Aflibercept In Subjects With Retinal Vein Occlusion

Conditions
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Macular Edema, Retinal Vein Occlusion

Intervention / Treatment
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* Drug: suprachoroidal CLS-TA
* Drug: suprachoroidal sham
* Drug: IVT aflibercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a clinical diagnosis of RVO in the study eye Has a CST of ≥ 300 µm in the study eye Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye; Is naïve to local pharmacologic treatment for RVO in the study eye; Exclusion Criteria: Any active ocular disease or infection in the study eye other than RVO History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring more than one medication Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study Any evidence of neovascularization in the study eye

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections | Drug: suprachoroidal CLS-TA<br>* suprachoroidal injection of CLS-TA<br>* Other names: Triamcinolone acetonide;Drug: IVT aflibercept<br>* 2 mg intravitreal injection of aflibercept<br>* Other names: Aflibercept;|
| Active Comparator: Control<br>IVT aflibercept (2 mg/0.05 mL) + sham SC procedure | Drug: suprachoroidal sham<br>* suprachoroidal sham procedure<br>Drug: IVT aflibercept<br>* 2 mg intravitreal injection of aflibercept<br>* Other names: Aflibercept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) | 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Best Corrected Visual Acuity | 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. A positive change from baseline value represents an improvement in vision. | 6 months | 
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RVO, ME, Central Subfield Thickness, OCT, Optical Coherence Tomography, Cystoid Macular Edema, Subretinal Fluid, Eylea, Aflibercept, Anti-VEGF, Suprachoroidal, Triamcinolone acetonide