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Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00788177
Recruitment Status : Unknown
Verified July 2009 by Klinikum Ludwigshafen.
Recruitment status was:  Recruiting
First Posted : November 10, 2008
Last Update Posted : September 27, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
Klinikum Ludwigshafen

Tracking Information
First Submitted Date  ICMJE November 7, 2008
First Posted Date  ICMJE November 10, 2008
Last Update Posted Date September 27, 2011
Study Start Date  ICMJE November 2008
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2008)
  • Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks [ Time Frame: 54 weeks ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2008)
  • Changes in best corrected visual acuity (BCVA) from baseline at 54 weeks [ Time Frame: 54 weeks ]
  • Mean change from baseline in at week 12 and 24 [ Time Frame: week 12 and 24 ]
  • Proportion of patients who gain ≥ 5, 10, 15 letters of BCVA from baseline at week 24 and 54 [ Time Frame: week 24 and 54 ]
  • Proportion of patients who lose less than 15 letters of BCVA from baseline at week 24 and 54 [ Time Frame: week 24 and 54 ]
  • Change in area of leakage at 12, 24 and 54 weeks [ Time Frame: weeks 12, 24 and 54 ]
  • Mean change in retinal thickness by OCT at center of fovea at 12, 24 and 54 weeks [ Time Frame: weeks 12, 24 and 54 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
 (submitted: November 7, 2008)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Lars-Olof Hattenbach, MD Department of ophthalmology, Ludwigshafen hospital
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