E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD).
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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 |
The objective of the CABERNET Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD).
The co-primary efficacy endpoints are: 1. Loss of 15 or more letters of best corrected visual acuity score at 12 months compared to baseline, and 2. Gain of 15 more letters of best corrected visual acuity score at 12 months compared to baseline. The trial will have shown benefit of the Epi-Rad90™ Ophthalmic System over Lucentis® if either: 1. The data demonstrate non-inferiority of Epi-Rad90™ Ophthalmic System over Lucentis® with regard to the proportion of eyes losing fewer than 15 or more ETDRS letters, with a non-inferiority margin of 10%, or 2. The data demonstrate superiority of Epi-Rad90™ Ophthalmic System over Lucentis® with regard to the proportion of eyes gaining 15 or more ETDRS letters.
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E.2.2 | Secondary objectives of the trial |
1. No loss in ETDRS letters 2. Mean change in ETDRS visual acuity 3. Change in total lesion size by fluorescein angiography 4. Change in total CNV size by fluorescein angiography 5. Number of rescue injections of Lucentis®
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must be age 50 or older; Best Corrected VA 20/40 to 20/320 Snellen All Lesion Subtypes: Predominantly Classic, Minimally Classic, or Occult Lesions MUST be Active. Subretinal Hemorrhage less than 50% of total lesion size & not in subfoveal space; Minimally Classic and Occult Lesions must have evidence of recent disease progression defined as: Presence of Subretinal Hemorrhage and/or Fluid and/or Lipid OR Loss of 1 or more lines of Vision / past 6 months OR FA documented lesion growth by ≥ 10% / past 6 months; Women Post-Menopausal ≥1 year or Surgically Sterilized |
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E.4 | Principal exclusion criteria |
Subjects with prior AMD Treatment Subjects with Concomitant Disease in the Study Eye (Uveitis, DR, ocular infections, etc.) Subjects with Glaucoma (IOP ≥ 30 mmHg) Subjects with Retinal Vasculopathies – RVO, Diabetic Retinopathy Subjects with any subfoveal scarring, atrophy, or hemorrhage CNV lesion has significant scarring and/or atrophy; Diagnosed Diabetes Mellitus; Previous Intra-ocular surgery, excluding cataract surgery |
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E.5 End points |
E.5.1 | Primary end point(s) |
The co-primary efficacy endpoints are: 1. Loss of 15 or more letters of best corrected visual acuity score at 12 months compared to baseline, and 2. Gain of 15 more letters of best corrected visual acuity score at 12 months compared to baseline. The trial will have shown benefit of the Epi-Rad90™ Ophthalmic System over Lucentis® if either: 1. The data demonstrate non-inferiority of Epi-Rad90™ Ophthalmic System over Lucentis® with regard to the proportion of eyes losing fewer than 15 or more ETDRS letters, with a non-inferiority margin of 10%, or 2. The data demonstrate superiority of Epi-Rad90™ Ophthalmic System over Lucentis® with regard to the proportion of eyes gaining 15 or more ETDRS letters.
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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 | 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 | Yes |
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 |
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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 |
NeoVista device + Lucentis is compared to Lucentis |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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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The primary endpoint of the trial is when all subjects reach the 12 month visit. 1 year has been the "gold standard" follow-up period for all AMD trials. As subjects are at risk for losing vision when not treated, or not responding to current standard of care therapy it is important to analyze the data at 1 year to determine treatment effect. Subjects will continue to be treated monthly for 24 months. Subjects will be followed for 36 months for safety. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |