Assessment of Patients Treated With JETREA® for Vitreomacular Traction
Research type
Research Study
Full title
Assessment of Anatomical and Functional Outcomes in Patients Treated with Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)
IRAS ID
149880
Contact name
Ajai Tyagi
Contact email
Sponsor organisation
Alcon Eye Care UK Ltd
Eudract number
2013-005464-25
Clinicaltrials.gov Identifier
Research summary
Under normal physiologic conditions, the vitreous maintains a gel-like consistency and adheres completely to the entire surface of the retina. The consistency of the vitreous and the adhesion to the retina are maintained by a matrix of proteins including collagen, laminin, and fibronectin. As part of the normal aging process, the protein structure of the vitreous progressively liquefies and the vitreoretinal adhesions weaken. This leads to separation of the posterior vitreous cortex
from the retinal internal limiting membrane – a process called posterior vitreous detachment (PVD). VMT can result in macular deformation and macular hole (MH), an opening in the retina that develops at the fovea. Until recently, vitrectomy was the only treatment for VMT/VMA and MH.9 Because of the risks associated with vitrectomy (including retinal detachment, hemorrhage, and cataract), vitrectomy is usually only performed once the loss of vision has become clinically significant.
Attempts at developing enzymes for vitreolysis against the substrates responsible for VMA have been generally unsuccessful. However, ocriplasmin has been developed and is approved by the European Medicines Agency (EMA) for treatment of VMT in adults, including when associated with macular hole of diameter less than or equal to 400 microns under the trade name JETREA®. In Canada, JETREA is indicated for the treatment of symptomatic vitreomacular adhesion (VMA).REC name
South Central - Oxford C Research Ethics Committee
REC reference
14/SC/0100
Date of REC Opinion
7 Mar 2014
REC opinion
Further Information Favourable Opinion