E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Typical findings in Type 2 idiopathic macular telangiectasia (type2-IMT)are parafoveal ectatic capillaries, The disease is characterized by a slow decrease in visual acuity, reading difficulties and/or metamorphopsia starting in the fifth to seventh decade. Both atrophy and secondary choroidal neovascularisation may occur with disease progression. So far there has been no therapy with proven benefit for type2-IMT. |
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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 | 10064761 |
E.1.2 | Term | Parafoveal telangiectasia |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary Objective: Improvement of best corrected visual acuity from baseline to 12 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters
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E.2.2 | Secondary objectives of the trial |
Secondary Objectives: 1. Assessment of changes on digital fundus photography 2. Quantitative and qualitative assessment of changes in Optical Coherence Topography (OCT) 3. Qualitative assessment of changes in fluorescein angiography 4. Registration of complications related to drug or its administration
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age >18 years • Written Informed Consent has been obtained. • Best corrected visual acuity in the study eye: 20/200 - 20/32.
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E.4 | Principal exclusion criteria |
• Patients with other retinal vascular diseases. such as Diabetic Retinopathy or retinal vascular occlusion • Previous intravitreal Injection of antiangiogenetic drugs into the study eye within the last 6 months. • Any surgery in the study eye within the last 3 months prior to inclusion into the study. • History of an uncontrolled glaucoma in the study eye • active inflammation in the study eye or the acular adnexa • Subfoveal fibrosis in the study eye • Inability to comply with the study protocol • Major general surgery one month prior to inclusion into the study • Known allergy to humanized antibodies • Pregnancy or insufficient contraception • History of serious cardio-vascular problems or stroke 6 months prior to inclusion into the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement of best corrected visual acuity from baseline to 12 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters |
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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 | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
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) | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | 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.8.5 | 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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The end of the study is the last subject undergoing the last visit as detailed in 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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |