E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Proliferative diabetic retinopathy |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036857 |
E.1.2 | Term | Proliferative diabetic retinopathy |
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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 |
Does injection into the eye of ranibizumab prior to undergoing vitrectomy surgery improve vision in patients with proliferative diabetic retinopathy? |
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E.2.2 | Secondary objectives of the trial |
Does injecting ranibizumab into the eye before undergoing vitrectomy surgery for proliferative diabetic retionopathy:
Make the surgery easier? Reduce the incidence of bleeding after the operation? Change the growth of new blood vessels in the retina? Alter the amount of retinal detachment present? Alter the blood flow to the macula?
Additionally, the study seeks to establish the levels of the drug in the eye at an interval after injection and compare this with levels detectable in the blood. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients of either sex aged 18 years or over 2. Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present: a) Current regular use of insulin for the treatment of diabetes b) Current regular use of oral anti-hyperglycaemic agents for the treatment of diabetes c) Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for Diagnosis of Diabetes) 3. Proliferative diabetic retinopathy with complications of this requiring vitrectomy surgery with anticipated delamination of pre-retinal fibrovascular complexes 4. Ability to return for study visits 5. Ability to give informed consent throughout the duration of the study
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E.4 | Principal exclusion criteria |
1. Hypersensitivity to the active substance or to any of the excipients. 2. Active or suspected ocular or periocular infections. 3. Vitreous haemorrhage presumed to be caused by vitreous traction on a single, focal point of vitreoretinal attachment 4. Cataract that, in the opinion of the investigators, would be significant enough to impair the view during surgery 5. Active severe intraocular inflammation 6. Previous vitrectomy surgery on study eye 7. Vision in fellow eye 3/60 or worse 8. Uncontrolled glaucoma 9. History of cerebrovascular accident, peripheral vascular disease, angina or myocardial infarction within six months prior to randomisation 10. Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation 11. Pregnancy or lactation 12. Unwillingness to use contraception for the duration of the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Absolute visual acuity at 12 weeks following surgery. |
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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 | No |
E.6.7 | Pharmacodynamic | No |
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Yes |
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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The final visit of the last subject at twelve weeks following surgery. |
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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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |