Status:
UNKNOWN
Subretinal Macugen® for Neovascular Age-Related Macular Degeneration
Lead Sponsor:
Klinikum Ludwigshafen
Collaborating Sponsors:
Pfizer
Conditions:
Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 sp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00788177
Start Date
November 1 2008
End Date
December 1 2012
Last Update
September 27 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Ophthalmology, Ludwigshafen hospital
Ludwigshafen, Germany, 67063