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

Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Study ID
NCT02767219
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    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.
  • 5-fluorouracil — DRUG
    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.
  • Dexamethasone — DRUG
    Both intervention groups will be given a subconjunctival injection of dexamethasone at the time of injection of either bevacizumab or 5-fluorouracil

Study Details

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.

Key Dates

First listed
May 10, 2016
Start date
May 31, 2016
Status verified
Aug 2021
Primary completion
Feb 28, 2019
Completion
May 31, 2019

Study Design

Enrollment
6 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Dexamethasone and 5-fluorouracil
    The control arm consists of current standard therapy of subconjunctival injections of dexamethasone 3.3mg/ml and pre filled syringes of 5-fluorouracil as required for 4 consecutive weeks after entry into the trial.
  • Active Comparator: Dexamethasone and Avastin
    Subconjunctival injections of dexamethasone 3.3mg/ml and pre filled syringes of bevacizumab will be given for 4 consecutive weeks from time of entry into trial

Primary Outcome Measure

Time taken to recruit 30 subjects (from start of study) [ Time Frame: study start date to18 months ]

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