Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
Status: | Terminated |
---|---|
Conditions: | Cardiology, Ocular, Ocular |
Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/11/2019 |
Start Date: | January 31, 2017 |
End Date: | December 10, 2018 |
SAPPHIRE: A RANDOMIZED, MASKED, CONTROLLED TRIAL TO STUDY THE SAFETY AND EFFICACY OF SUPRACHOROIDAL CLS-TA IN CONJUNCTION WITH INTRAVITREAL AFLIBERCEPT IN SUBJECTS WITH RETINAL VEIN OCCLUSION
This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12
months duration in treatment naïve subjects with RVO.
months duration in treatment naïve subjects with RVO.
A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal
CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal veinocclusion
CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal veinocclusion
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
We found this trial at
59
sites
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9001 Wilshire Boulevard
Beverly Hills, California 90211
Beverly Hills, California 90211
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University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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1101 East Missouri Avenue
Phoenix, Arizona 85014
Phoenix, Arizona 85014
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