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

Phase 3

Terminated

• Conditions: Retinal Vein Occlusion; Macular Edema
• Interventions: Drug: suprachoroidal CLS-TA; Drug: suprachoroidal sham; Drug: Lucentis or Avastin

• Registration Number: NCT03203447
• Lead Sponsor: Clearside Biomedical, Inc.

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-06-29
• Study Start: 2018-03-05
• Primary Completion: 2018-12-18
• Study Completion: 2018-12-18
• Disposition First Submitted: 2019-12-13
• Results First Submitted: 2021-03-18
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-22
• Disposition First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Results First Posted: 2021-04-23
• Disposition First Posted: 2021-04-23
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 325

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Lucentis or Avastin	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
Active	suprachoroidal CLS-TA	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
Control	suprachoroidal sham	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
Control	Lucentis or Avastin	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

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)	2 months	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Best Corrected Visual Acuity	6 months	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.
Mean Change From Baseline in Central Subfield Thickness	6 months	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.

Trial Locations

Locations (86)

Retinal Research Institute; 🇺🇸 Phoenix, Arizona, United States

Retina Centers PC; 🇺🇸 Tucson, Arizona, United States

Retina Associates Southwest PC; 🇺🇸 Tucson, Arizona, United States

Win Retina; 🇺🇸 Arcadia, California, United States

Retina Vitreous Medical Group; 🇺🇸 Beverly Hills, California, United States

Retinal Diagnostic Center; 🇺🇸 Campbell, California, United States

Retina Consultants of Orange County; 🇺🇸 Fullerton, California, United States

Macula and Retina Institute; 🇺🇸 Glendale, California, United States

American Institute of Research; 🇺🇸 Whittier, California, United States

Retina Vitreous Associates Medical Group Inc; 🇺🇸 Mountain View, California, United States

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