E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) |
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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 | 10060837 |
E.1.2 | Term | Choroidal neovascularization |
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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 |
1. The main purpose of this amendment is to extend the study duration. Based upon feedback from Health Authorities in France, Sweden and USA the study is extended to allow collection of long term (2 years) safety data. In addition, collection of treatment pattern related data for up to 2 years would allow better differentiation between Visudyne and Lucentis combination arms and Lucentis monotherapy in terms of possibly reduced treatment burden. Study results may be used for label extension. 2.Correct data of the sponsor. |
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E.2.2 | Secondary objectives of the trial |
Objectives of the trial have been changed for an extension of the trial from 12 to 24 months |
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E.2.3 | Trial contains a sub-study | No |
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) ≤ 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 ≥ 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 thefellow 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) |
The two primary efficacy variables are • mean change from baseline in best corrected visual acuity (BCVA) at month 12 • the proportion of patients with a treatment-free interval of at least 3 months duration at any timepoint following Month 2 The primary analysis will be performed on the ITT population using the LOCF approach for imputing missing data |
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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 | No |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Assessment of patients treatment satisfaction and treatment preferences. |
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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 | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 37 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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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 | |
E.8.9.2 | In all countries concerned by the trial years | 2 |