Subretinal Macugen® for Neovascular Age-Related Macular Degeneration
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Klinikum Ludwigshafen.
Recruitment status was Recruiting
Information provided by:
First received: November 7, 2008
Last updated: September 26, 2011
Last verified: July 2009
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.
Age-related Macular Degeneration
Drug: Pegaptanib (Macugen®)
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Subretinal Macugen® for Neovascular Age-Related Macular Degeneration (SUMANA)
Primary Outcome Measures:
- Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
- Mean change from baseline in total size of lesion and total size of CNV at 12, 24 and 54 weeks [ Time Frame: week 24 and 54 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in best corrected visual acuity (BCVA) from baseline at 54 weeks [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
- Mean change from baseline in at week 12 and 24 [ Time Frame: week 12 and 24 ] [ Designated as safety issue: No ]
- Proportion of patients who gain ≥ 5, 10, 15 letters of BCVA from baseline at week 24 and 54 [ Time Frame: week 24 and 54 ] [ Designated as safety issue: No ]
- Proportion of patients who lose less than 15 letters of BCVA from baseline at week 24 and 54 [ Time Frame: week 24 and 54 ] [ Designated as safety issue: No ]
- Change in area of leakage at 12, 24 and 54 weeks [ Time Frame: weeks 12, 24 and 54 ] [ Designated as safety issue: No ]
- Mean change in retinal thickness by OCT at center of fovea at 12, 24 and 54 weeks [ Time Frame: weeks 12, 24 and 54 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2012 (Final data collection date for primary outcome measure)
Drug: Pegaptanib (Macugen®)
Pegaptanib administered to the subretinal space (first dose) and to the vitreous cavity (following doses)
Other Name: Macugen®, Pfizer Pharma GmbH
|Ages Eligible for Study:
||50 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00788177
|Department of Ophthalmology, Ludwigshafen hospital
|Ludwigshafen, Germany, 67063 |
|Contact: Lars-Olof Hattenbach, MD +49 (621) 503 3051 Hattenbl@klilu.de |
|Principal Investigator: Lars-Olof Hattenbach, MD |
||Lars-Olof Hattenbach, MD
||Department of ophthalmology, Ludwigshafen hospital
No publications provided
||Lars-Olof Hattenbach, MD, Privatdozent, Department of ophthalmology, Ludwigshafen hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 7, 2008
||September 26, 2011
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Klinikum Ludwigshafen:
age-related macular degeneration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 20, 2014
Wet Macular Degeneration