MedTrace Logo

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

NCT02767219 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-08-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Moorfields Eye Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Rashmi Mathew, FRCOphthMBBS · Moorfields Eye Hospital NHS Trust

  • Jonathan Clarke, FRCOphthMBBS · Moorfields Eye Hospital NHS Trust

  • Keith Barton, FRCOphthMBBS · Moorfields Eye Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-02-28
Completion
2019-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02767219 on ClinicalTrials.gov