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

Clearside Biomedical

Status and phase: Terminated; Phase 3

Conditions: Macular Edema; Retinal Vein Occlusion

Treatments: Drug: suprachoroidal CLS-TA; Drug: suprachoroidal sham; Drug: Lucentis or Avastin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03203447

CLS1003-302

Details and patient eligibility

About

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.

Full description

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

Enrollment: 325 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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325 participants in 2 patient groups

Active

Active Comparator group

Description:

Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection

Treatment:

Drug: Lucentis or Avastin

Drug: suprachoroidal CLS-TA

Control

Sham Comparator group

Description:

Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure

Treatment:

Drug: suprachoroidal sham

Drug: Lucentis or Avastin