SAPPHIRE - A randomised study for participants with RVO
Research type
Research Study
Full title
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
IRAS ID
220629
Contact name
Simon Taylor
Contact email
Sponsor organisation
Clearside Biomedical, Inc.
Eudract number
2016-004648-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
This study is a randomised controlled study to evaluate the efficacy and safety of suprachoroidal CLS TA in conjunction with intravitreal aflibercept in participants with retinal vein occlusion (RVO). RVO is a common, sight threatening visual disorder in patients over 40 years of age. Macular oedema (MO) is the major reason for vision loss, particularly if it is inadequately treated, but intraocular injections of both corticosteroids and anti-VEGF agents have been shown to be effective treatments for this, and both are licensed treatments in the UK.
However, not all patients respond well, and multiple injections over several years can be required. There is some evidence that a dual strategy may be beneficial, so Clearside Biomedical, Inc., the sponsor, is exploring this further in this study. Using a combined approach potentially enables different aspects of the disease to be tackled in parallel and offers the opportunity for more rapid and better clinical outcomes.CLS-TA is an investigational product, which will be used in conjunction with an already approved medication called Aflibercept (EYLEA®). The active group, receiving Aflibercept plus real CLS-TA injections, will be compared to the control group, receiving Alibercept plus fake injections of CLS TA (no CLS TA is actually given). The suprachoroidal injection is an intraocular injection procedure that is well tolerated, with previous clinical trials showing the most common adverse event to be mild eye pain.
Eligible patients will be asked to attend the study site up to 12 times during the duration of the study and will be randomly assigned 1:1 to one of the two treatment groups. Of note, all patients will receive active treatment with the standard-of-care drug Eylea; the active group will also receive the injections of the investigational treatment CLS-TA. The study duration is approximately 12 months and approximately 460 patients will take part in the study globally.
REC name
London - Riverside Research Ethics Committee
REC reference
17/LO/0933
Date of REC Opinion
12 Sep 2017
REC opinion
Further Information Favourable Opinion