Vitreous haemorrhage secondary to proliferative diabetic retinopathy
Conditions
Sponsors
Moorfields Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Non-clearing or recurrent vitreous haemorrhage due to proliferative diabetic retinopathy – indicated for PPV. Visual acuity better than perception of light. Patient fit for and agreed to have pars plana vitrectomy Age > 20 years old Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous vitrectomy Ocular and systemic contra-indication for vitrectomy Unfit for local or general anaesthesia Inability to obtain visual acuity, fundus imaging or fluorescein angiogram. Reduced potential visual acuity due to corneal or optic nerve disease, or amblyopia Previous intravitreal Avastin® injection in either eye Inability to give informed consent Inability to comply with follow-up visit and investigation Women of child-bearing age or currently breast feeding Recent (< 1 month) acute myocardial infarct, transient ischaemic attack or stroke.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if pre-operative and intra-operative intravitreal Avastin® in vitrectomy for diabetic vitreous haemorrhage will reduce the rate of post-operative vitreous haemorrhage. ;Primary end point(s): Frequency of vitreous haemorrhage within 6 months after operation;Secondary Objective: Secondary Outcomes 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. Vitreous Avastin® and growth factor levels at 2 weeks after injection. 7. Serum Avastin® and growth factor levels at 2 and 4 weeks after injection. Safety Outcomes 1. Incidence and severity of ocular adverse events 2. Incidence and severity of non-ocular adverse events 3. Changes in vital signs | — |
Countries
United Kingdom
Outcome results
None listed