Subretinal Macugen® for Neovascular Age-Related Macular Degeneration
NCT ID: NCT00788177
Last Updated: 2011-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
10 participants
INTERVENTIONAL
2008-11-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Pegaptanib (Macugen®)
Pegaptanib administered to the subretinal space (first dose) and to the vitreous cavity (following doses)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Klinikum Ludwigshafen
OTHER
Responsible Party
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Department of ophthalmology, Ludwigshafen hospital
Principal Investigators
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Lars-Olof Hattenbach, MD
Role: PRINCIPAL_INVESTIGATOR
Department of ophthalmology, Ludwigshafen hospital
Locations
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Department of Ophthalmology, Ludwigshafen hospital
Ludwigshafen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AU-06102G
Identifier Type: -
Identifier Source: org_study_id