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ISRCTN
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ISRCTN79120387
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ClinicalTrials.gov identifier
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Public title
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A randomised, single-masked, phase IV pilot study of the efficacy and safety of adjunctive intravitreal Avastin® (bevacizumab) in the prevention of early postoperative vitreous haemorrhage following diabetic vitrectomy
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Scientific title
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Acronym
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N/A
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Serial number at source
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4.1
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Study hypothesis
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This pilot study is designed to explore and evaluate the feasibility of using pre- and intra-operative intravitreal Avastin® in diabetic vitrectomy for vitreous haemorrhage.
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Ethics approval
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Moorfields and Whittington Research Ethics Committee, South House, Block A, Royal Free Hospital, Pond Street, London, NW3 2QG, UK. Approved on 11th July 2007 (ref: 07/H0721/58)
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Study design
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Single-centre, randomised, single-masked, controlled study.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Proliferative diabetic retinopathy
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Participants - inclusion criteria
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1. A diagnosis of non-clearing or recurrent vitreous haemorrhage due to proliferative diabetic retinopathy - indicated for Pars Plana Vitrectomy (PPV)
2. Visual acuity better than perception of light
3. Patient fit for and agreed to have PPV
4. >20 years old
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Participants - exclusion criteria
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1. Previous vitrectomy
2. Ocular and systemic contra-indication for vitrectomy
3. Unfit for local or general anaesthesia
4. Inability to obtain visual acuity, fundus imaging or fluorescein angiogram
5. Reduced potential visual acuity due to corneal or optic nerve disease, or amblyopia
6. Previous intravitreal Avastin® injection in either eye
7. Inability to give informed consent
8. Inability to comply with follow-up visit and investigation
9. Women of childbearing age
10. Recent (<1 month) acute myocardial infarct, Transient Ischaemic Attack (TIA) or stroke
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Anticipated start date
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01/10/2007
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Anticipated end date
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30/09/2010
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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30
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Interventions
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Avastin® will be administered intravitreally in a single or dual-dose regimen of 1.25 mg (in 0.05 ml) 2 weeks prior to vitrectomy and at the end of vitrectomy if internal tamponade (oil, air or gas) was not used. No sham intravitreal injections will be given before or after vitrectomy if patient is randomized to the usual treatment group.
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Primary outcome measure(s)
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Post-operative vitreous haemorrhage based on two masked clinical assessments at 6 weeks and 6 months.
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Secondary outcome measure(s)
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The following will be assessed at the time of vitrectomy, at 6 weeks and 6 months after vitrectomy:
1. Recruitment and drop out rates
2. Rates of re-operation for recurrent vitreous haemorrhage
3. Rate of post-operative rubeosis and rubeotic glaucoma
4. Rate and severity of intraoperative bleed
5. Mean change in ETDRS acuity and MNRead acuity
6. Serum Avastin® and growth factor levels at 2 and 4-6 weeks after injection. Vitreous levels at 2 weeks after injection.
Safety outcome measures:
1. Incidence and severity of ocular adverse events
2. Incidence and severity of non-ocular adverse events
3. Changes in vital signs
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Sources of funding
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Moorfields Eye Hospital NHS Foundation Trust (UK)
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Trial website
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Publications
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Contact name
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Mr
Lyndon
da Cruz
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Address
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Moorfield Eye Hospital
162 City Road
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City/town
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London
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Zip/Postcode
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EC1V 2PD
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Country
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United Kingdom
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Sponsor
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Moorfields Eye Hospital NHS Foundation Trust (UK)
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Address
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162 City Road
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City/town
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London
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Zip/Postcode
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EC1V 2PD
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Country
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United Kingdom
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Sponsor website:
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http://www.moorfields.nhs.uk/Home
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Date applied
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18/09/2007
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Last edited
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11/01/2008
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Date ISRCTN assigned
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11/01/2008
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