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
| ISRCTN | ISRCTN79120387 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79120387 |
| Secondary identifying numbers | 4.1 |
- Submission date
- 18/09/2007
- Registration date
- 11/01/2008
- Last edited
- 14/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Lyndon da Cruz
Scientific
Scientific
Moorfield Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
Study information
| Study design | Single-centre randomised single-masked controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific 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 |
| Study objectives | 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. |
| Ethics approval(s) | Moorfields and Whittington Research Ethics Committee, 11/07/2007, ref: 07/H0721/58 |
| Health condition(s) or problem(s) studied | Proliferative diabetic retinopathy |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bevacizumab |
| Primary outcome measure | Post-operative vitreous haemorrhage based on two masked clinical assessments at 6 weeks and 6 months. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/10/2007 |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 30/09/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Moorfield Eye Hospital
London
EC1V 2PD
United Kingdom
EC1V 2PD
United Kingdom
Sponsor information
Moorfields Eye Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
162 City Road
London
EC1V 2PD
England
United Kingdom
| Website | http://www.moorfields.nhs.uk/Home |
|---|---|
"ROR" |
https://ror.org/03zaddr67 |
Funders
Funder type
Government
Moorfields Eye Hospital NHS Foundation Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
14/06/2016: No publications found, verifying study status with principal investigator.
