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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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN79120387 |
| Date ISRCTN assigned | 11/01/2008 |
| Local reference number(s) | 4.1 |
| Public title | 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 |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Proliferative diabetic retinopathy |
| Study hypothesis | 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. |
| Design/methodology | Single-centre, randomised, single-masked, controlled study. |
| Research ethics review | 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) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 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 |
| Participants - exclusion criteria | 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 |
| Patient information material | |
| Anticipated start date | 01/10/2007 |
| Anticipated end date | 30/09/2010 |
| Status of trial | Ongoing |
| Target number of participants | 30 |
| Interventions | 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. |
| Primary outcome measure(s) | Post-operative vitreous haemorrhage based on two masked clinical assessments at 6 weeks and 6 months. |
| Secondary outcome measure(s) | 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 |
| Sources of funding | Moorfields Eye Hospital NHS Foundation Trust (UK) |
| Sponsor name | Moorfields Eye Hospital NHS Foundation Trust (UK) |
| Sponsor details | 162 City Road London United Kingdom EC1V 2PD |
| Sponsor website | http://www.moorfields.nhs.uk/Home |
| Contact name | Mr Lyndon da Cruz |
| Contact details | Moorfield Eye Hospital 162 City Road London United Kingdom EC1V 2PD |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN79120387 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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