TOPAZ - A randomised study for participants with RVO
Research type
Research Study
Full title
A RANDOMIZED, MASKED, CONTROLLED TRIAL TO STUDY THE SAFETY AND EFFICACY OF SUPRACHOROIDAL CLS-TA IN COMBINATION WITH AN INTRAVITREAL ANTI-VEGF AGENT IN\nSUBJECTS WITH RETINAL VEIN OCCLUSION\nProtocol No: CLS1003-302
IRAS ID
242004
Contact name
Kathleen Billman
Contact email
Sponsor organisation
Clearside Biomedical, Inc
Eudract number
2017-002089-37
Clinicaltrials.gov Identifier
115683, IND Number
Duration of Study in the UK
1 years, 5 months, 7 days
Research summary
Retinal vein occlusion (RVO) is a common, sight threatening visual disorder that is most common in people over 40 years of age. Retinal vein occlusion occurs because one of the veins that carry blood out of the retina becomes blocked. When the main vein becomes blocked, it is called central retinal vein occlusion (CRVO). When branches of the main vein become blocked, it is called branch retinal vein occlusion (BRVO). This blockage of a retinal vein leads to low blood flow and low oxygen levels accompanied by fluid leakage and swelling of the blood vessels in the area of the eye drained by the blocked vein. The severity and outcome depends on 2 things: the amount of blood flow and the\namount of fluid leakage in the macula of the eye (macular oedema [MO]).\nParticipants are being asked to participate in a medical research study that involves injections of a corticosteroid called CLS TA, triamcinolone acetonide injectable suspension, into the suprachoroidal space (SCS) of the eye affected by RVO (“the study eye”).\nThe purpose of this study is to see if suprachoroidal (SC) injections of CLS TA, given together with intravitreal (IVT) injections of LUCENTIS® (ranibizumab) or AVASTIN® (bevacizumab), in participants who have MO after RVO are safe and work better than LUCENTIS® (ranibizumab) or AVASTIN® (bevacizumab) alone. LUCENTIS® (ranibizumab) and AVASTIN® (bevacizumab) belong to a group of medication injections known as anti-vascular endothelial growth factor (VEGF) injections. These medicines can help reduce the swelling of the macula.\nThe study drug, CLS TA, will be administered by using an investigational, specially developed microinjector delivery system. The system was developed by the Sponsor, Clearside Biomedical, Inc., to inject drugs into the SCS.\nApproximately 460 participants worldwide, will be allocated to treatment arms (ACTIVE and CONTROL, with 230 in each arm) and with each arm having 2 different groups.\nThe following study assessments are required: medical and eye disease history, demographic questions, laboratory tests (blood and urine), brief physical examination, various eye tests, eye photographs, questionnaires and blood pressure and heart rate.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
18/YH/0219
Date of REC Opinion
27 Sep 2018
REC opinion
Further Information Favourable Opinion