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

Clearside Biomedical

Status and phase: Completed; Phase 2

Conditions: Macular Edema; Retinal Vein Occlusion

Treatments: Drug: IVT aflibercept; Drug: 4 mg CLS-TA; Drug: Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT02303184

CLS1003-201

Details and patient eligibility

About

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).

Full 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

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups

4 mg CLS-TA + IVT aflibercept

Experimental group

Description:

Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept

Treatment:

Drug: 4 mg CLS-TA

Drug: IVT aflibercept

sham + IVT aflibercept

Active Comparator group

Description:

Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept

Treatment:

Drug: Sham

Drug: IVT aflibercept