E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
CENTRAL AND BRANCH RETINAL VEIN OCCLUSION |
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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 |
To investigate visual acuity outcomes following intravitreal Bevacizumab (Avastin™) in patients with BRVO and CRVO.
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E.2.2 | Secondary objectives of the trial |
To explore the structural and functional mechanisms of intravitreal Bevacizumab (Avastin™) on neovascular AMD as assessed by fundus photography, fluorescein angiography, optical coherence tomography, and microperimetry.
To evaluate ocular adverse events following intravitreal Bevacizumab (Avastin™).
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Signed informed consent • CRVO or BRVO • No requirement for panretinal laser coagulation • No active proliferative disease (NVD/NVE/rubeosis) • Patients with BRVO will only included if vision is better than 0.4 or if previous focal laser coagulation has shown no significant improvement in vision. • Retinal thickness of at least 250µm due to intraretinal or subretinal edema as measured by OCT.
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E.4 | Principal exclusion criteria |
Prior/Concomitant Treatment • Previous vitrectomy • Laser coagulation within the last 3 month • Previous participation in any studies of investigational drugs within 3 month preceding Day 0 including intravitreal Triamcinolone Concurrent Ocular Conditions • Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either Require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 12-month study period • Active intraocular inflammation (grade trace or above) in the study eye • Current vitreous hemorrhage in the study eye • History of idiopathic or autoimmune-associated uveitis in either eye • Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye • Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0 • Uncontrolled glaucoma in the study eye (defined as intraocular pressure 30 mmHg despite treatment with anti-glaucoma medication) • History of vitrectomy or complicated cataract surgery with rupture of the posterior lens capsule Concurrent Systemic Conditions • Any planned ocular surgery within the study period. • Patients on anticoagulation therapy other than Aspirin. • Premenopausal women not using adequate contraception The following are considered effective means of contraception: surgical sterilization; use of oral contraceptives; barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel; an IUD; or contraceptive hormone implant or patch. • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications • Current treatment for active systemic infection Other • History of allergy to fluorescein, not amenable to treatment • Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the investigators • Inability to comply with study or follow up procedures
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E.5 End points |
E.5.1 | Primary end point(s) |
Visual acuity outcomes as measured by the ETDRS protocol in patients with CRVO/BRVO. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Information not present in EudraCT |
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) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |