Neovascular (exudative) age-related macular degeneration MedDRA version: 9.1 Level: LLT Classification code 10015902 Term: Exudative senile macular degeneration of retina
Conditions
Interventions
Trade Name: Macugen
Product Name: Macugen (Pegaptanib)
Pharmaceutical Form: Injection*
INN or Proposed INN: Pegaptanib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
Society (Institute) for clinical research
Eligibility
Sex/Gender
All
Inclusion criteria
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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Safety and tolerability of the new drug administration root (first dose).;Primary end point(s): Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks measured by ETDRS charts | — |
Countries
Germany
Outcome results
None listed