The use of bevacizumab as a modulator of wound healing following trabeculectomy surgery: A Single Centre Randomised Controlled Phase III Pilot Study. - Role of avastin and 5-fluorouracil in trabeculectomy surgery (RAFTS)

Moorfields Eye Hospital NHS Foundation Trust0 个研究点目标入组 30 人开始时间: 2016年1月19日最近更新: 2020年7月27日

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•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

•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.
•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.

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