NCT02767219

The Use of Bevacizumab as a Modulator of Wound Healing Following Trabeculectomy Surgery

The Use of Bevacizumab as a Modulator of Wound Healing Following Trabeculectomy Surgery: A Single Centre Randomised Controlled Phase III Pilot Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Moorfields Eye Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III randomised controlled pilot study which aims to assess the effectiveness of the use of bevacizumab in patients who have undergone trabeculectomy surgery, which appear to be showing early signs of failure.

Detailed description

Pharmacological enhancement of trabeculectomy using Mitomycin C (MMC) has significantly improved success rates. Despite this, some patients still mount aggressive scarring responses post-operatively and require additional subconjunctival injections 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. Vascular 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 5-Fluorouracil (5-FU) are therefore often considered when these clinical findings are apparent, in order to modify the course of wound healing. The investigators 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-Fluorouracil (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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DRUG	bevacizumab	Patients will be randomised to study arms with a 1:1 ratio. Once randomised, Group 2 will receive a subconjunctival injection of bevacizumab and a subconjunctival injection of dexamethasone 3.3mg/ml. This will be given for 4 consecutive weeks from time of entry into trial.
DRUG	5-fluorouracil	Patients will be randomised to study arms with a 1:1 ratio. Once randomised, Group 1 will receive a subconjunctival injection of 5-fluorouracil and a subconjunctival injection of dexamethasone 3.3mg/ml. This will be given as required for 4 consecutive weeks from time of entry into trial. This is current standard practice.
DRUG	Dexamethasone	Both intervention groups will be given a subconjunctival injection of dexamethasone at the time of injection of either bevacizumab or 5-fluorouracil

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-02-01
• Completion: 2019-05-01
• First posted: 2016-05-10
• Last updated: 2021-08-17

Locations

1 site across 1 country: United Kingdom