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
Protocol serial number	4.1
Sponsor	Moorfields Eye Hospital NHS Foundation Trust (UK)
Funder	Moorfields Eye Hospital NHS Foundation Trust (UK)

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

Moorfield Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom

Study information

Primary study design	Interventional
Study design	Single-centre randomised single-masked controlled study
Secondary study design	Randomised controlled trial
Study type	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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Bevacizumab
Primary outcome measure(s)	Post-operative vitreous haemorrhage based on two masked clinical assessments at 6 weeks and 6 months.
Key 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
Completion date	30/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Moorfield Eye Hospital

London
EC1V 2PD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/06/2016: No publications found, verifying study status with principal investigator.