Study to Determine the Safety and Effectiveness of CLS-TA in Combination with an Intravitreal Anti-VEGF Agent in Subjects with Retinal Vein Occlusion
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-001892
Sponsor Protocol Number: CLS1003-302
About this study
The purpose of this study is to demonstrate the safety and effectiveness of CLS-TA ("suprachoroidal CLS-TA") used in combination with an anti-VEGF agent ("intravitreal anti-VEGF agent") in subjects with retinal vein occlusion (RVO).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Raymond Iezzi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available