E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This case-series is designed to evaluate the safety and efficacy of intravitreal ranibizumab (Lucentis®) in the treatment of macular edema due to central retinal vein occlusion. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007972 |
E.1.2 | Term | Central retinal vein occlusion |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054467 |
E.1.2 | Term | 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 |
Explore whether intravitreal ranibizumab is an effective, safe and convenient treatment for patients with macular edema due to central retinal vein occlusion. Aim of the study is to increase the visual acuity by 15 EDTRS letters in 50% of the patients. |
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E.2.2 | Secondary objectives of the trial |
Anzahl der Patienten/Patientinnen mit Visusverlust um mehr als 15 ETDRS Buchstaben, Anzahl der Patienten/ Patientinnen mit Anstieg um 15 Symbolen an den Pelli Robson Charts, Veränderung der zentralen Netzhautdicke mittels OCT; Veränderungen der Scores des NEI-VFQ-25 Fragebogens |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients who at baseline 1. have a best corrected visual acuity (BCVA) in the study eye between 20/40 to 20/400 (EDTRS charts, visual acuity measured at 4 meters). 2. have clinical, angiographical and optical coherence tomography (OCT) evidence (central retinal thickness >250µm) of macular edema due to CRVO. 3. are willing and able to provide written informed consent. 4. are willing to return for the scheduled visits for a 12 month period. 5. Only one eye will be assessed in the study. If both eyes are eligible, the one with worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigators deem the other eye the more appropriate candidate for treatment and study.
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E.4 | Principal exclusion criteria |
Patients who at baseline 1. are younger than 19 years of age. 2. are mentally disabled. 3. are participating in another clinical study. 4 show a decrease in visual acuity due to causes other than CRVO e.g. history of exudative age-related macular degeneration, diabetic macular edema, choroidal neovascularizations of any cause. 5. had prior intravitreal anti-VEGF or intravitreal/periocular corticosteroid treatment of CRVO. 6. have concomitant use of corticosteroids (by any route) for the duration of study participation (chronic use is defined as multiple doses taken daily for three or more consecutive days at any time during the study). 7. have a history of radial optic neurotomy. 8. have a history of vitreo-retinal surgery in the study eye or anticipated surgery within the next 12 months. 9. have a history of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with topical anti-glaucomatous medication). 10. show presence of vitreoretinal traction or epiretinal gliosis affecting central vision. 11. had any intraocular surgery (cataract surgery or Yag Capsulotomy) within 3 months prior to enrolment. 12. present with neovascular glaucoma, iris neovascularization, vitreous hemorrhage in the study eye. 13. have aphakia or absence of the posterior capsule in the study eye. 14. show uncontrolled arterial hypertension and/or diabetes mellitus. 15. have a history of myocardial infarction or stroke within 6 months prior to enrolment.
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the changes in visual acuity from baseline at 12 months in patients treated with intravitreal ranibizumab. |
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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 | 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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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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Please refer to the protocol |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |