Role of avastin and 5-fluorouracil in trabeculectomy surgery (RAFTS)
Research type
Research Study
Full title
The use of bevacizumab as a modulator of wound healing following trabeculectomy surgery: A Single Centre Randomised Controlled Phase III Pilot Study.
IRAS ID
122193
Contact name
Jonathan Clarke
Contact email
Sponsor organisation
Moorfields Eye Hospital NHS Foundation Trust
Eudract number
2013-000395-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 30 days
Research summary
Pharmacological enhancement of trabeculectomy using MMC has significantly improved success rates. Despite this, some patients still mount aggressive scarring responses post-operatively and require additional subconjunctival injection of antifibrotic agents, such as 5-Fluorouracil (5-FU) to reduce scar formation and reduce the likelihood of surgical failure. There is concern that these agents are potentially toxic and may result in side effects such as keratopathy (loss of corneal epithelium) and are also painful for the patient. For those patients that are showing clinical evidence of potential scar formation, a more predictable and less toxic modulator of wound healing is desirable.\nVascular endothelial growth factor (VEGF) has been associated with angiogenesis in numerous pathological situations, including tumor growth, proliferative retinopathy, and rheumatoid arthritis. VEGF is also thought to play a pivotal role in ocular wound healing. It mediates the signal transduction cascade leading to tenon’s fibroblast migration and proliferation and collagen gel contraction at the site of surgery, as well as angiogenesis. VEGF also causes persistent vascular permeability and vasodilation at the level of existing microvessels. Vessels with increased permeability are typically tortuous and dilated and this is the clinical appearance within the conjunctiva, suggestive of future excessive wound healing and scar formation following trabeculectomy. Early interventions such as subconjunctival injections of 5FU are therefore often considered when these clinical findings are apparent, in order to modify the course of wound healing.\n We propose a pilot study looking at the effect of serial injections of bevacizumab (an anti-VEGF agent) on modifying the wound healing response in patients showing early signs of future failure, compared to 5-FU. The purpose of the pilot is to also gather outcome data and information relating to safety and recruitment with a view to powering a definitive study addressing this issue.\n
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/0180
Date of REC Opinion
10 Mar 2016
REC opinion
Further Information Favourable Opinion