E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
subfoveal choroidal neovascularization secondary to age-related macular degeneration |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060823 |
E.1.2 | Term | Choroidal neovascularisation |
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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 |
The primary objective is to evaluate the safety and the efficacy of ranibizumab administered in conjunction with photodynamic therapy in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD) and to evaluate if this treatment reduces the total number of ranibizumab retreatment and permittes a the treatment-free interval longer. |
|
E.2.2 | Secondary objectives of the trial |
Evaluate: Percentage of the patients that gain ≥5 ≥10 ≥15 Letters, BCVA at 3,6,12 months; Percentage of the patients that lose <15 letters at 3,6,12 months; Mean BCVA change and change of the total area of the lesion from baseline; Change of fluorangiographic leakage at 3,6,12 months from baseline; Retinal sensitivity change measured with microperimetry. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male or female patients of any race 50 years or older with subfoveal CNV secondary to AMD(all types of lesion).The total area of CNV encompassed within the lesion must be>50% of the total lesion area.The total lesion area must have the greatest linear dimension ≤5400 microns(9 MPS Disc Areas). BCVA letter score in the study eye between 73 and 24 (approximately 20/40 to 20/320 Snellen Equivalent) using an ETDRS chart measured at 4 meters distance. |
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E.4 | Principal exclusion criteria |
Any prior treatments with Visudyne, Macugen, Lucentis(Ranibizumab), Avastin(Bevacizumab) or other anti-angiogenic or corticosteroid intravitreal treatment in the study eye; Prior external-beam radiation, subfoveal focal laser photocoagulation, transpupillary thermotherapy,pars plana vitrectomy in the study eye; History of intraocular surgery in the study eye except for uncomplicated cataract surgery more than 90 days prior to treatment; History of YAG-laser posterior capsulotomy in the study eye within 30 days prior treatment; Use of non steroid antinflammatory drugs during the study; Presence of angioid streaks, presumed ocular histoplasmosis syndrome, pathologic myopia(8 or more D); Presence of fibrosis,hemorrage, pigment epithelial detachments or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion; Tear (rip) of the retinal pigment epithelium; Vitreal hemorrage,retinal detachment or macular hole; Epiretinal membrane; Uncontrolled glaucoma in the study eye(defined as intraocular pressure, IOP ≥ 25 mmHG despite treatment with two or more topical pharmacological antiglaucomatous medication); Active or history of ocular inflammation or infection; Aphakia and posterior capsule tear; Pregnant or nursing(lactating) women; Women of child-bearing potential unless they meet the following definition of postmenopausal; Any systemic medical condition that may interfere with the safety of the patient; Positive anamnesis for tumor in last the 5 years. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluate mean BCVA change at 3,6,12 months from baseline using an ETDRS chart measured at 4 meters distance; Evaluate the number of retreatments, the treatment free interval and the percentage of retreated patients at 3,6,12 months; leakage change at 3,6,12 months from baseline. |
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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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
STUDIO IN APERTO DELLA DURATA DI 12 MESI |
|
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
| 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 | 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
| |
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 |