E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neovascular wet age-related macular degeneration AMD |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10038896 |
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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 |
Demonstrate that Visudyne combination therapy is not inferior to Lucentis monotherapy with respect to the mean change from baseline in Best-Corrected Visual Acuity BCVA letters at Month 12. Evaluate the proportion of patients with a treatment-free interval of at least 3 months duration at any timepoint following Month 2. BCVA . |
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E.2.2 | Secondary objectives of the trial |
Demonstrate that Visudyne combination therapy is superior to Lucentis monotherapy, based on the number of Lucentis retreatments administered over 9 months following the Month 2 treatment. Evaluate the time to first retreatment of Lucentis by comparing Visudyne combination therapy with Lucentis monotherapy following the Month 2 Lucentis treatment Assess the safety of Visudyne combination therapy compared to Lucentis monotherapy as assessed by ophthalmic and vital signs evaluations and adverse event AE reports over 12 months Evaluate the efficacy of Visudyne combination therapy compared to Lucentis monotherapy on BCVA changes from baseline as assessed by Early Treatment Diabetic Retinopathy Study ETDRS charts and visual acuity VA protocol over 12 months Evaluate the efficacy of Visudyne combination therapy compared to Lucentis monotherapy on changes in angiographic and optical coherence tomography OCT outcomes from baseline over 12 months |
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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 Primary or recurrent active subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component The total area of CNV including both classic and occult components encompassed within the lesion must be 50 of the total lesion area as defined by fluorescein angiography FA The total lesion are must have the Greatest Linear Dimension GLD 8804; 5400 microns 9 MPS Disc Areas DA If the lesion is classified as occult with no classic CNV component, the lesion must have evidence of recent disease progression as defined in the study glossary under active lesion BCVA letter score in the study eye between 73-24 approximately 20/40 to 20/320 Snellen equivalent using an ETDRS chart measured at 4 meters distance Patients who provide written and informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure Patients willing and able to comply with all study procedures |
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E.4 | Principal exclusion criteria |
Ocular concomitant conditions/ diseases Presence of angioid streaks, presumed ocular histoplasmosis syndrome, pathologic myopia -8 or more with evidence of posterior segment abnormalities consistent with pathologic myopia , or CNV secondary to causes other than AMD Presence of fibrosis, hemorrhage, pigment epithelial detachments, or other hypofluorescent lesions obscuring greater than 50 of the CNV lesion Tear rip of the retinal pigment epithelium Active, or history of, ocular inflammation or infection in the study eye within 30 days prior to Screening Uncontrolled glaucoma in the study eye defined as intraocular pressure, IOP 8805; 25 mmHg despite treatment with two or more topical pharmacological anti-glaucomatous medication Any concurrent ocular condition in the study eye that may result in visual loss during the study Ocular treatments Prior Visudyne , external-beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye Prior treatment with Macugen , Lucentis , Avastin bevacizumab or other anti-angiogenic compound or any investigational treatment e.g. Ruboxistaurin, Retaane anecortave acetate , squalamine, siRNA, VEGF-Trap etc. for neovascular AMD in the study eye treatment of the fellow eye is permitted if administered 30 days before Screening History of intraocular surgery in the study eye including pars plana vitrectomy, except for uncomplicated cataract surgery more than 60 days prior to screening History of YAG laser posterior capsulotomy in the study eye within 30 days prior to screening |
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E.5 End points |
E.5.1 | Primary end point(s) |
Demonstrate that Visudyne combination therapy is not inferior to Lucentis monotherapy with respect to the mean change from baseline in best-corrected visual acuity BCVA letters at Month 12. Evaluate the proportion of patients with a treatment-free interval of at least 3 months duration at any timepoint following Month 2 |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
ranibizumab e vertepo e ranibizumab in monoterapia |
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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.8.5 | The trial involves multiple Member States | Yes |
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
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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 | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |