E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with choroidal neovascularization secondary to pathologic myopia. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060823 |
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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 evaluate the safety of Pegaptanib in myopic neovascular lesions after 1 year from the first treatment. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Choroidal neovascularization secondary to pathologic myopia (distance correction of at least -6.0 D, or less than -6.0 D but with retinal abnormalities consistent with pathologic myopia, and an axial length at least 26.5 mm) Choroidal neovascularization under the geometric center of the foveal avascular zone Area of choroidal neovascularization at least 50% of the area of the total neovascular lesion Greatest linear dimension no more than 5400 m Best-correct visual acuity letter score of at least 50 (Snellen equivalent 20/100 or better) Willing and able to provide written informed consent. |
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E.4 | Principal exclusion criteria |
Features of any condition other than pathologic myopia associated with choroidal neovascularization in study eye Tear (rip) of the retinal pigment epithelium Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome Inability of obtain photographs to document choroidal neovascularization History of treatment for choroidal neovascularization in study eye other than nonfoveal confluent laser photocoagulation Participation in another ophthalmic clinical trial or use of any other investigational new drugs within 12 weeks before the start of study treatment Prior photodynamic therapy for choroidal neovascularization Intraocular surgery within last 2 months or capsulotomy within last months in study eye Women in pregnancy and breast-feeding or women who have intention of having one pregnancy in the period of time of duration of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the safety of Pegaptanib on visual acuity. |
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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 | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
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 | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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
| |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |