Subretinal Macugen® for Neovascular Age-Related Macular Degeneration
NCT00788177
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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).
- 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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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Subretinal Macugen® for Neovascular Age-Related Macular Degeneration | |||
| Official Title ICMJE | Subretinal Macugen® for Neovascular Age-Related Macular Degeneration (SUMANA) | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Age-related Macular Degeneration | |||
| Intervention ICMJE | Drug: Pegaptanib (Macugen®)
Pegaptanib administered to the subretinal space (first dose) and to the vitreous cavity (following doses) Other Name: Macugen®, Pfizer Pharma GmbH | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Unknown status | |||
| Estimated Enrollment ICMJE | 10 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Estimated Study Completion Date ICMJE | December 2012 | |||
| Estimated Primary Completion Date | March 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 50 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Germany | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00788177 | |||
| Other Study ID Numbers ICMJE | AU-06102G | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Lars-Olof Hattenbach, MD, Privatdozent, Department of ophthalmology, Ludwigshafen hospital | |||
| Study Sponsor ICMJE | Klinikum Ludwigshafen | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | Klinikum Ludwigshafen | |||
| Verification Date | July 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||