E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vitreous haemorrhage secondary to proliferative diabetic retinopathy |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequency of vitreous haemorrhage within 6 months after operation |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the trial is when 30 patients in each arm of the study has been recruited. As this is a pilot study, we will need to know drop out rate of the study to plan further studies. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |