Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF 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 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.

Key facts

Study ID

NCT03203447

Run by

Clearside Biomedical, Inc.

People needed

325

Starts

2018-03-05

Expected to finish

2018-12-18

Last updated by the study team

2021-04-23

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

• 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 — Los Angeles, California, United States
• Retina Vitreous Associates Medical Group Inc — Mountain View, California, United States
• Stanford University - Byers Eye Institute — Palo Alto, California, United States
• Retina Consultants of Southern California — Redlands, California, United States
• Retina Consultants Medical Group Inc — Sacramento, California, United States
• American Institute of Research — Whittier, California, United States
• Retina Group of New England, PC — New London, Connecticut, United States
• Florida Eye Microsurgical Institute — Boynton Beach, Florida, United States
• Specialty Retina Center — Coral Springs, Florida, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Center for Retina Care at The Eye Institute — Melbourne, Florida, United States
• Florida Retina Institute — Orlando, Florida, United States
• Eye Associates of Pinellas — Pinellas Park, Florida, United States
• Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States
• East Florida Eye Institute EFEI — Stuart, Florida, United States
• Southern Vitreoretinal Association — Tallahassee, Florida, United States
• Center for Retina And Macular Disease — Winter Haven, Florida, United States
• Retinal Research Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.