E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with macular edema due to diabetic retinopathy |
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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 | 10060837 |
E.1.2 | Term | Choroidal neovascularization |
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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 |
Evaluation of short term efficacy of the Lucentis® pretreatment to laser photocoagulation compared to the combined laser photocoagulation and Lucentis® treatment in patients with clinical significant diabetic macula edema. The main focus of assessments of efficacy is: 1. The percent change in macular edema measured with standard optical coherence tomography (OCT) 2. The absolute change in visual acuity analyzed by standardized charts according to the protocol used in the Early Retreatment in Diabetic Retinopathy Study (ETDRS) |
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E.2.2 | Secondary objectives of the trial |
To explore the effect of pretreatment with Lucentis compared to combined treatment with laser photocoagulation and Lucentis on diabetic macular edema as assessed by percent change in incidence and interval of Lucentis retreatments, percent change in macular edema measured with OCT and percent change in visual acuity (% of gained Letters) using ETDRS charts. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria - Signed informed consent - Age> = 18 years - Patients with type 1 or 2 diabetes mellitus - Patients with diabetic macular edema with center involvement - Central macular thickness (macular edema) of at least 300 microns in the central subfield as measured by OCT - Best corrected visual acuity, using ETDRS charts; of 78 (20/32) to 24 (20/320) in the study eye
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E.4 | Principal exclusion criteria |
- A condition that would preclude the patient for participation in the study in opinion of investigator, e.g., unstable blood pressure(systolic > 180, diastolic > 110) and unstable glycemic control (Hb1Ac levels > = 9% or recent change in glycamic therapy to intensive Insulin treatment within the past 6 months). - Pregnency or nursing - History of previous heart attack or stroke within the past 6 months - History of allergic reaction to treatment with Ranibizumab - Glaucoma patients with unstable intraocular pressure (> 25 mmHg)
Prior/Concomitant treatment in study eye - Macular laser photocoagulation or intravitreal treatment within the past 3 months - Panretinal laser photocoagulation within the past 3 months - Previous intraocular surgery, e.g., vitrectomy and retinal detachment treatment within the past 6 months - History of submacular surgery or other surgical intervention for diabetic macular edema
Concurrent Ocular Conditions - Active intraocular inflammation - Macular edema due to ocular disorders including retinal vascular occlusion, retinal detachment, uveitis or postoperatively in the study eye - Vitreomacular traction in the study eye evident by OCT
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | No |
E.8.1.3 | Single blind | Yes |
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 |
laser photocoagulation treatment |
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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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End of Trial is the visit at month 6 Patients must be withdrawn under following circumstances: 1. at their own request 2. if the investigator thinks that continuation would not be in the interest of the patient 3. if the patient violets the conditions laid out in the consent form/information sheet or disgards instructions by the study personel |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |