Condition category
Eye Diseases
Date applied
18/09/2007
Date assigned
11/01/2008
Last edited
14/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Lyndon da Cruz

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4.1

Study information

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

Acronym

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.

Ethics approval

Moorfields and Whittington Research Ethics Committee, 11/07/2007, ref: 07/H0721/58

Study design

Single-centre randomised single-masked controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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 names

Bevacizumab

Primary outcome measures

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 trial start date

01/10/2007

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

01/10/2007

Recruitment end date

30/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Moorfield Eye Hospital
London
EC1V 2PD
United Kingdom

Sponsor information

Organisation

Moorfields Eye Hospital NHS Foundation Trust (UK)

Sponsor details

162 City Road
London
EC1V 2PD
United Kingdom

Sponsor type

Government

Website

http://www.moorfields.nhs.uk/Home

Funders

Funder type

Government

Funder name

Moorfields Eye Hospital NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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