Role of Avastin and 5-Fluorouracil in Trabeculectomy Surgery

Phase 1

• Conditions: Primary Open Angle Glaucoma; MedDRA version: 18.1Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2013-000395-15-GB
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-19
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:
All of the criteria listed below must be present in order for the patient to be eligible for enrolment in the study.

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).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

If any of the following exclusion criteria are present, the patient will not be entered into the study.

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 >160mmHg or diastolic blood pressure >90mmHg
5.Subject hypersensitive to bevacizumab, 5-FU, and mitomycin-C and its excipients

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

6.No light perception.
7.Aphakia
8.Previous ocular surgery: vitreo-retinal, conjunctival surgery
9.Complicated cataract surgery
10.Cataract surgery less than 6 months in duration
11.Secondary glaucoma, other than PDS and PXF
12.Ocular trauma within the past 3 months
13.Active iris neovascularization or active proliferative retinopathy.
14.Severe posterior blepharitis.
15.Unwilling to discontinue contact lens use after surgery.
16.Conjunctival scarring precluding a superior trabeculectomy.
17.Need for glaucoma surgery combined with other ocular procedures (ie cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.
18.Current or recent (<3months) use of bevacizumab into the study eye.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified