E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Maculare edema secondary to Central Retinal Vein Occlusion |
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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 | 10054467 |
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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 | 10007972 |
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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 |
To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on best-corrected visual acuity (BCVA) assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart in subjects with macular edema secondary to CRVO |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of IVT administered VEGF Trap-Eye in subjects with macular edema secondary to CRVO. To assess the effects of IVT administered VEGF Trap-Eye on central retinal thickness (CRT) in subjects with macular edema secondary to CRVO. To assess the pharmacokinetics of free and bound VEGF Trap in a subset of patients |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Center-involved macular edema secondary to CRVO for no longer than 9 months with mean central subfield thickness ≥ 250 μm on OCT. Adults ≥ 18 years. ETDRS BCVA of 20/40 to 20/320 (73 to 24 letters) in the study eye. For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to screening) and other prescription pharmaceutical contraceptives, intrauterine device (IUD), bilateral tubal ligation, vasectomy, condom, or diaphragm plus either contraceptive sponge, foam, or jelly. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures. Willingness to provide written informed consent |
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E.4 | Principal exclusion criteria |
1. Only one functional eye even if that eye is otherwise eligible for the study. Furthermore, subjects with only one eligible eye should not have other ocular conditions with poorer prognosis in the fellow eye. 2. Any prior or concomitant ocular (in the study eye) treatment or surgery for macular edema secondary to CRVO, or systemic use of anti-VEGF products [...]PLEASE SEE PROTOCOL PAGE 21 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of subjects who gain at least 15 letters in BCVA on the EDTRS chart compared with baseline at the Week 24 endpoint. |
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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 | 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 | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 49 |
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 | 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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End of trial is last visit of last subject |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | |
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 | 10 |