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

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust
• Treatments: BB 1101; Bevacizumab; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fluorouracil

Criteria

Inclusion Criteria:

1. Age 18 to 85 years, inclusive

2. Patient must have undergone standard trabeculectomy augmented with Mitomycin C, within the past 4-6 weeks.

3. Patients who in the clinician's opinion are mounting an aggressive wound healing response and demonstrate objective increase in bleb vascularity (moderate or severe on MBGS). Bleb function still needs to be maintained in the clinicians opinion and flat, scarred blebs are not to be included.

Exclusion Criteria:

1. Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.

2. Pregnant or nursing women.

3. A history of cardiovascular or cerebrovascular events in the previous 6 months, such as angina, arrhythmia, Transient Ischaemic Attack, strokes, myocardial infarction.

4. Uncontrolled hypertension defined as systolic blood pressure >160millimeters of mercury (mmHg) or diastolic blood pressure >90millimeters of mercury (mmHg)

5. Subject hypersensitive to bevacizumab, 5-Fluorouracil (5-FU), and Mitomycin-C (MMC) and its excipients

6. Failed trabeculectomy bleb

7. Persistent wound leak following trabeculectomy at the time of randomisation

The following exclusions apply to the study eye only (i.e. they may be present for the non study eye

8. No light perception.

9. Aphakia

10. Previous, or planned, ocular surgery: vitreo-retinal, conjunctival surgery, etc considered likely to interfere with trabeculectomy outcome

11. Complicated cataract surgery

12. Cataract surgery less than 6 months in duration

13. Secondary glaucoma, other than Pigment Dispersion Syndrome (PDS) and Pseudoexfoliative (PXF)

14. Ocular trauma within the past 3 months

15. Active iris neovascularization or active proliferative retinopathy.

16. Severe posterior blepharitis.

17. Unwilling to discontinue contact lens use after surgery.

18. Current or recent (<3months) use of bevacizumab into the study eye.