E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Submacular choroidal neovascularisation in Age-related Macular Degeneration |
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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 assess which combination of laser treatment (photodynamic therapy = PDT) and injection (of triamcinolone into the vitreous within the eye) is most effective in preventing loss of vision (visual acuity) due to submacular new vessel ingrowth in age-related macular degeneration. Untreated this condition has an almost 100% of legal blindness. Patients will be allocated at random into 2 study arms.The two arms in the study are 1. Trimcinolone injection preceding PDT 2. PDT before the Trimcinolone injection |
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E.2.2 | Secondary objectives of the trial |
- Lesion size at one year, adjusted for baseline lesion size. - Number of treatments required in first year after randomisation. - Incidence of serious complications. - Vision-specific and generic health status questionnaires: NEIVFQ(25); SF-36. - Contrast sensitivity threshold (Pelli-Robson contrast sensitivity chart). |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male or female 2. The patient must be willing to give written Informed consent. 3. The patient must be able to undertake the necessary tests and treatment and be willing to be followed up. 4. Age 50 years or older. 5. Clinical diagnosis of AMD. 6. Classic, Predominantly classic or occult CNV on fluorescein angiography. 7. LogMAR visual acuity of >35 letters on a 2m or 4m EDTRS chart. 8. Does not have open angle glaucoma. 9. Is not a steroid responder for intraocular pressure
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E.4 | Principal exclusion criteria |
1. Inability to understand or sign consent form. 2. The patient has a current medical condition or history of a medical condition that would be likely to preclude scheduled study visits such as unstable angina, dialysis, active cancer. 3. Patient has a current ophthalmic condition or history of an ophthalmic condition that might compromise the assessment of the treatment such as diabetic retinopathy, uveitis, amblyopia, and ischaemic optic neuropathy. 4. Signs of a myopic retina or refraction of > -6 dioptres in their current or previous glasses prescription 5. Signs of other retinal conditions that may have caused the CNV such as angioid streaks, choroidal rupture, old chorio-retinitis. 6. At increased risk of developing glaucoma such as having; pigment dispersion syndrome or pseudo-exfoliation 7. Unable to have a good quality fluorescein angiogram taken e.g. due to; head tremor or media opacity. 8. Allergic to fluorescein or verteporfin or triamcinolone acetonide. 9. Previous treatment for a retinal detachment. 10. Judged by the examining clinician to be at increased risk of retinal detachment due to weaknesses in the peripheral retina. 11. Patient is currently participating or has participated in a clinical trial that utilized an investigational drug or treatment within 30 days prior to enrolment to this study. 12. On anticoagulation therapy such as warfarin, with the exception of aspirin and other anti-platelet therapy. 13. < 35 letters on the ETDRS logMAR chart. 14. Inability to read a logMAR chart. 15. Intraocular surgery in study eye within 60 days prior to planned enrolment in study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Visual acuity [VA] at 1 year (EDTRS logMAR chart at 2m, letters read), adjusted for baseline logMAR VA. |
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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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 trial will end 1 year after enrollment of the last patient. |
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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 | |
E.8.9.1 | In the Member State concerned days | |