E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Macular edema secondary to branch retinal vein occlusion |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025415 |
E.1.2 | Term | Macular oedema |
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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 |
This prospective randomized trial is designed to compare the functional and anatomic outcomes of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a combination of both. We intend to explore whether intravitreal ranibizumab alone or in combination with argon laser photocoagulation is equivalent or superior to laser photocoagulation alone for patients with chronic macular edema secondary to BRVO. |
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E.2.2 | Secondary objectives of the trial |
Safety of intravitreal ranibizumab injections will be studied further. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adults aged 18 years and older with chronic (>3 months, <18 months) macular edema secondary to branch retinal vein occlusion • Patients who at baseline have a best spectacle-corrected visual acuity (BSCVA) in the study eye between 20/320 and equivalent to 20/40, using an ETDRS chart measured at 4 meters •Patients who at baseline have a chronic macular edema (>3 months) in the study eye with the following characteristics as determined by fluorescein angiography: o Evidence that the macular edema extends under the geometric center of the foveal avascular zone. o Evidence that the edema is only secondary to BRVO (no other relevant ocular diseases, e. g. uveitis). • Patients who at baseline have a chronic macular edema (>3 months) in the study eye with the following characteristics as determined by optical coherence tomography (OCT 3): o Evidence that central macular thickness is >225 µm. • Ability of subject to understand character and individual consequences of clinical trial. • Signed and dated informed consent of the subject must be available before start of any specific trial procedures. • For women with childbearing potential, adequate contraception (negative pregnancy test result, serum or urine at trial entry, after treatment and at end of study)
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E.4 | Principal exclusion criteria |
• Patients who at baseline o have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, neovascular age- related macular degeneration, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, and others) o have a relevant systemic disease which may be associated with increased systemic VEGF levels (namely all malignancies) o had previous treatment for macular edema (laser, triamcinolone, vitrectomy) • Pregnancy and lactation. • History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. • Participation in other clinical trials within the last 3 months. • Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
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E.5 End points |
E.5.1 | Primary end point(s) |
The changes in best spectacle-corrected visual acuity (BSCVA) from baseline to month 6 in patients treated with intravitreal ranibizumab alone versus laser group versus patients who received a combination of both treatment options. |
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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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
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 | 3 |
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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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |