Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO

Phase 3TerminatedNCT03203447

Clearside Biomedical, Inc.325 enrolled

Overview

This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone.

A Randomized, Masked, Controlled Trial to Study the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Anti-VEGF Agent in Subjects With Retinal Vein Occlusion

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

325

Conditions

Macular Edema Retinal Vein Occlusion

Interventions

suprachoroidal CLS-TADRUG

suprachoroidal injection of CLS-TA

suprachoroidal shamDRUG

sham suprachoroidal procedure

Lucentis or AvastinDRUG

IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (92)

Outcomes

Primary Outcomes

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.

Time frame: 2 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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