Age-related Macular Degeneration
Conditions
Keywords
age-related macular degeneration, subretinal injection, Pegaptanib, Macugen
Brief summary
The purpose of this study is to assess the efficacy of pegaptanib (Macugen®) for neovascular (exudative) age-related macular degeneration (AMD) when the first dose is administered to the submacular space instead of vitreous body in cases when previous state-of-the-art treatment for the AMD was deemed ineffective.
Interventions
DRUGPegaptanib (Macugen®)
Pegaptanib administered to the subretinal space (first dose) and to the vitreous cavity (following doses)
Sponsors
Pfizer
Klinikum Ludwigshafen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 50 years and older with neovascular AMD proven by FA * 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).
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 |
|---|---|
| Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks | 54 weeks |
| Mean change from baseline in total size of lesion and total size of CNV at 12, 24 and 54 weeks | week 24 and 54 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who gain ≥ 5, 10, 15 letters of BCVA from baseline at week 24 and 54 | week 24 and 54 |
| Proportion of patients who lose less than 15 letters of BCVA from baseline at week 24 and 54 | week 24 and 54 |
| Changes in best corrected visual acuity (BCVA) from baseline at 54 weeks | 54 weeks |
| Mean change in retinal thickness by OCT at center of fovea at 12, 24 and 54 weeks | weeks 12, 24 and 54 |
| Change in area of leakage at 12, 24 and 54 weeks | weeks 12, 24 and 54 |
| Mean change from baseline in at week 12 and 24 | week 12 and 24 |
Countries
Germany
Contacts
Primary ContactLars-Olof Hattenbach, MD
Outcome results
None listed