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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Macular Edema, Retinal Vein Occlusion

In brief

This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.

Key facts

Study ID

NCT02980874

Run by

Clearside Biomedical, Inc.

People needed

460

Starts

2017-01-31

Expected to finish

2018-12-10

Last updated by the study team

2021-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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

Where it is running

• Retinal Consultants of Arizona and Retinal Research Institute — Phoenix, Arizona, United States
• Arizona Retina and Vitreous Consultants — Phoenix, Arizona, United States
• Associated Retina Consultants, Ltd. — Phoenix, Arizona, United States
• Retina Centers P.C. — Tucson, Arizona, United States
• California Retina Research Consultants — Bakersfield, California, United States
• Retina Vitreous Medical Group Clinical Research — Beverly Hills, California, United States
• Atlantis Eyecare — Huntington Beach, California, United States
• Jacobs Retina Center at the Shiley Eye Institute, UCSD — La Jolla, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• East Bay Retina Consultants Inc. — Oakland, California, United States
• Southern California Desert Retina Consultants — Palm Desert, California, United States
• Retina Institute of California — Palm Desert, California, United States
• Retina Consultants San Diego — Poway, California, United States
• Orange County Retina Medical Group — Santa Ana, California, United States
• California Retina Consultants CRC — Santa Barbara, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• Colorado Retina Associates — Golden, Colorado, United States
• New England Retina Associates — Hamden, Connecticut, United States
• MedEye Associates — Miami, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• Emory Eye Center — Atlanta, Georgia, United States
• Associated Retina Consultants, Ltd. — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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