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

Phase 2

Completed

• Conditions: Macular Edema; Retinal Vein Occlusion
• Interventions: Drug: 4 mg CLS-TA; Drug: Sham; Drug: IVT aflibercept

• Registration Number: NCT02303184
• Lead Sponsor: Clearside Biomedical, Inc.

Brief Summary

A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).

Detailed Description

A randomized, masked, controlled trial of safety and efficacy of suprachoroidal CLS-TA in combination with intravitreal aflibercept in subjects with macular edema following retinal vein occlusion

Study Timeline

• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-11-27
• Study Start: 2015-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Disposition First Submitted: 2018-01-31
• Disposition First Submitted QC: 2018-01-31
• Disposition First Posted: 2018-02-05
• Status Verified: 2021-01
• Results First Submitted: 2021-01-18
• Results First Submitted QC: 2021-01-18
• Last Update Submitted: 2021-01-18
• Results First Posted: 2021-02-08
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• diagnosis of macular edema following RVO
• History of ME ≤ 12 months
• 20-70 letters inclusive BCVA using ETDRS

Exclusion Criteria

• has had an IVT injection of anti-VEGF for RVO in the study eye
• has had a corticosteroid injection in the past 3 months in the study eye
• any uncontrolled ophthalmic condition in the study eye other than RVO

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 mg CLS-TA + IVT aflibercept	4 mg CLS-TA	Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept
4 mg CLS-TA + IVT aflibercept	IVT aflibercept	Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept
sham + IVT aflibercept	Sham	Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
sham + IVT aflibercept	IVT aflibercept	Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept

Primary Outcome Measures

Name	Time	Method
Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm	3 months