E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neovascular (exudative) age-related macular degeneration |
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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 | 10015902 |
E.1.2 | Term | Exudative senile macular degeneration of retina |
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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 assess the efficacy of pegaptanib for neovascular (exudative) age-related macular degeneration (AMD) when the first dose is administered to the subretinal space instead of vitreous body. Following doses will be administered to the vitreous cavity. |
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E.2.2 | Secondary objectives of the trial |
Safety and tolerability of the new drug administration root (first dose). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects meeting all of the following criteria will be considered for admission to the trial: • adults aged 50 years and older with neovascular AMD proven by fluorescein angiography • Patients who at baseline - have a BCVA letter score in the study eye between 20/40 to 20/320 using an ETDRS chart measured at 4 meters or Snellen equivalent -have a CNV lesion of any type in the study eye with the following characteristics as determined by fluorescein angiography: - Evidence that CNV extends under the geometric center of the foveal avascular zone. • Previous state-of-the-art therapy for the disease is deemed ineffective with following characteristics are given: - Loss of visual acuity (2 or more Snellen lines) in the previous 3 months defined as either OR - ≥10% increase in the lesion diameter as assessed by fluorescein angiography in the previous 3 months • 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. • Women with childbearing potential practicing a medically accepted contraception (negative pregnancy test result, serum or urine at trial entry).
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E.4 | Principal exclusion criteria |
Subjects presenting with any of the following criteria will not be included in the trial: • have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, retinal vessel occlusion) • had previous vitrectomy surgery for whatsoever reason • are not pseudophakic • have a >50% area of scarring of the whole CNV lesion size as seen in FA • Arterial hypertension refractory to medical treatment • 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 during the present clinical trial or within the last 3 months. • Medical or psychological condition that would not permit completion of the trial or signing of informed consent. • Suspected or present ocular or periocular infection
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks measured by ETDRS charts |
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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 | Yes |
E.7.1.3.1 | Other trial type description |
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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 | No |
E.8.1.1 | Randomised | No |
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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Prospectively defined case series |
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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
| 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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Last visit of the last patient as defined in the study 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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |