Primary Open Angle Glaucoma MedDRA version: 18.1 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Avastin
Product Name: Bevacizumab (Avastin) 0.05mls of 5mg/0.2ml
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Bevacizumab
CAS Number: 216974-75-3
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the pilot study is to assess acceptability of the proposed treatment to patients, evaluate our trial SOPs such as randomisation and masking, and to gather information on the efficacy and safety of the new treatment combination which will be used to design a definitive randomized controlled study. Objectives 1) To gather information on the safety profile of the proposed therapy 2) To assess recruitment rates 3) To gather information of different outcome measures (intraocular pressure, bleb morphology, number of post-operative interventions, time to failure, number of topical ocular hypotensive agents after surgery, complications). ;Secondary Objective: Secondary Outcome 1) To gather information on different outcome measures (intraocular pressure, bleb morphology, number of post-operative interventions, time to failure, number of topical ocular hypotensive agents after surgery, complications). ;Primary end point(s): The Primary Outcome measures are: 1) Time taken to recruit 30 subjects (from start of study) 2) Proportion of patients who are eligible, who agree to be randomised 3) Proportion of patients who are lost to follow-up or who withdraw from the study. ;Timepoint(s) of evaluation of this end point: The evaluation will take place 18 months after LVLS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome measures are: 1. Intraocular pressure 2. Bleb morphology (as determined by Moorfields Bleb Grading system) 3. Number of additional postoperative interventions with 5-fluorouracil (5-FU) and subconjunctival dexamethasone, following the 4 week trial intervention period; bleb needling. (received between surgery and 18 months of follow up) 4. Time to failure 5. Number of topical ocular hypotensive medications at 3 months and 18 months 6. The incidence of the following complications will be recorded: hypotony (IOP < 6mmHg at 2 consecutive post-operative visits after 3 months), hypotony maculopathy, wound leakage and bleb leakage, bleb-related infections (blebitis, bleb-related endophthalmitis). ;Timepoint(s) of evaluation of this end point: The evaluation will take place 18 months after LVLS | — |
Countries
United Kingdom
Contacts
Public ContactMays Jawad
Moorfields Eye Hospital
Outcome results
None listed