E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Exudative Age Related Macular Degeneration (AMD) |
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MedDRA Classification |
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 provide Pegaptanib Sodium Injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD who have previously enrolled in a Macugen study. . Patients will continue to be treated under this protocol until such time as the product becomes commercially available or the patient’s lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Ophthalmic Criteria 1. Best corrected visual acuity in the study eye worse than 20/40. 2. Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size [including blood, scar/atrophy & neovascularization] of < 12 total disc areas, of which at least 50% must be active CNV. 3. Any subretinal hemorrhage must comprise no more than 50% of total lesion size. 4. Intraocular pressure of 23mmHg or less.
General Criteria 1. Patients of either gender, aged 50 years. 2. Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication. 3. Patients have completed participation in the other Macugen AMD study. 4. Written informed consent.
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E.4 | Principal exclusion criteria |
Patients will not be eligible for treatment if any of the following criteria are present systemically or in the study eye:
1. Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy. 2. Patients who are eligible for any other of the Sponsor’s ongoing AMD studies still open to enrollment. 3. Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of –8 diopters or more, or axial length of 25mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis. 4. Any of the following underlying diseases including: - History or evidence of severe cardiac disease e.g. NYHA Functional Class III or IV (e.g. marked limitation of activity due to fatigue, palpitation or dyspnea, or worse), myocardial infarction within 6 months, ventricular tachyarrythmias requiring ongoing treatment or unstable angina. - Stroke (within 12 months of study entry) - Acute ocular or periocular infection 5. Known serious allergies to the fluorescein dye used in angiography (and indocyanine green if used) or to the components of Pegaptanib sodium formulation.
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E.5 End points |
E.5.1 | Primary end point(s) |
There are no efficacy end points |
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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 | 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) | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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To be continued until commerically available |
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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 | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 15 |