E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic Maculopathy: Clinically significant macular oedema
To understand the effects of intravitreal triamcinolone (IVTA) in the treatment of clinically significant macular edema (CSME) in diabetics who have concurrent cataract which requires intervention. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057915 |
E.1.2 | Term | Diabetic macular oedema |
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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 |
To understand the effects of intravitreal triamcinolone (IVTA) in the treatment of clinically significant macular edema (CSME) in diabetics who have concurrent cataract which requires intervention. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with Type 1 or Type 2 diabetes mellitus diagnosed according to the 1999 WHO standard
2. Patients with cataract sufficient in an eye to either cause visual symptoms such as reduced visual acuity, glare, material index myopia, or monocular polyopia, or sufficient to impair fundus visualisation for macular laser treatment of clinically significant macular edema (CSME) as defined by the Early Treatment Diabetic Retinopathy Study (ETDRS) 14
3. Patients who have persistent CSMO despite previous laser treatment and have concurrent visual impairment considered partially due to cataract.
4. Patients who have moderate, severe non proliferative diabetic retinopathy, and treated proliferative diabetic retinopathy as defined by a clinical modification 15 of the ETDRS final retinopathy severity scale 16 .
5. Optical Coherence Tomography III (OCT) measurements of >300 micron at central subfield of fast macula map pre-operatively at the time of listing.
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E.4 | Principal exclusion criteria |
1. Patients with no CSME
2. High-risk proliferative retinopathy as defined by the Diabetic Retinopathy Study (DRS) . Patients in whom high-risk proliferative retinopathy had regressed at least 4 months following appropriate laser treatment were considered eligible.
3. Diabetes associated with specific genetic syndromes (type A insulin resistance); induced by drugs, chemicals, or endocrinopathies; or secondary to pancreatic tumour or pancreatectomy.
4. Coexistent ocular disease likely to modify visual acuity, for example age-related macular degeneration, amblyopia, retinal venous occlusion.
5. Coexistent disease likely to significantly affect retinopathy progression, for example severe carotid occlusive disease, high myopia, glaucoma. Patients with renal dysfunction are however, included in the study, as dictated by the need to recruit sufficient patients with more severe retinopathy, in whom some renal impairment was common.
6. Patients with coexistent disease likely to respond poorly to side effects of intravitreal triamcinalone including glaucoma, ocular hypertension, steroid responders.
7. Prior intraocular surgery to either eye.
8. Complicated cataract surgery.
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E.5 End points |
E.5.1 | Primary end point(s) |
Resolution of CSME at 12 months following cataract surgery with intravitreal triamcinolone injection. |
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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 | No |
E.6.5 | Efficacy | No |
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) | 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 | Yes |
E.8.2.3 | Other | No |
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 trial at 12 month follow up. Patients will continue regular diabetic retinopathy follow up in medical retina clinic. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |