E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic Macular Edema (DME) |
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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 | 10057934 |
E.1.2 | Term | Diabetic macular edema |
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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 of this trial is to evaluate the ocular and non-ocular adverse events during the 24-months study period in patients treated with Lucentis (0.5 mg)
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are:
• •To describe the ocular and non-ocular adverse events during the 12-months study period •To describe the ocular and non-ocular adverse events over a cumulative 24-months period - including the core and the 12 months extension study • To describe the ocular and non-ocular adverse events over a cumulative 36-months period - including the core and extension study •To evaluate the change of the best-corrected visual acuity (BCVA) over the first 12-months of the study period •To evaluate the change of the best-corrected visual acuity (BCVA) over 24-months study period- including the core and the 12 months extension study • To evaluate the change of the best-corrected visual acuity (BCVA) over the 24- months study period • To evaluate the change of the best-corrected visual acuity (BCVA) over 36-months study period- including the core and the extension study |
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E.2.3 | Trial contains a sub-study | Yes |
E.3 | Principal inclusion criteria |
1. Patients must have completed the RESTORE study assessments at Month 12
2. Patients must give written informed consent before any study related activity of this extension protocol is performed.
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E.4 | Principal exclusion criteria |
a. Use of investigational drugs, other than those provided in RESTORE (RFB002D2301) study at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer b. Current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol c. History of hypersensitivity to ranibizumab or any component of the ranibizumab formulation d. Uncontrolled glaucoma in either eye ( IOP > 24 mmHg on medication or according to investigator’s judgment) e. Evidence of vitreomacular traction in either eye at visit 14 f. Active proliferative diabetic retinopathy in the study eye at visit 14 g. Intravitreal corticosteroid treatment in a phakic study eye during the core study h. Intravitreal corticosteroids in post-cataract surgical study eye (aphakic or pseudophakic without damaged posterior capsule) within 3 months prior to Visit 14 i. Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular corticosteroids at visit 14 j. Any type of advanced, severe or unstable disease or its treatment, that could interfere with primary and/or secondary outcome evaluations including any medical condition that could be expected to progress, recur, or change to such an extend that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk k. History of stroke or transient ischemic attack (TIA) l. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. m. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) n. Inability to comply with study or follow-up procedures.
No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary analysis will be the estimation of incidences of adverse events. |
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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 | Yes |
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) | Yes |
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 | No |
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
| 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 | 55 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
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 | No |
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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |