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 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 trial start date
01/10/2007
Overall trial end date
30/09/2010
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list