Proliferative diabetic retinopathy Eye Diseases Diabetic retinopathy
Conditions
Interventions
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) w
Sponsors
Moorfields Eye Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative vitreous haemorrhage based on two masked clinical assessments at 6 weeks and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed