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Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Klinikum Ludwigshafen.
Recruitment status was:  Recruiting
Information provided by:
Klinikum Ludwigshafen Identifier:
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.

Condition Intervention Phase
Age-related Macular Degeneration
Drug: Pegaptanib (Macugen®)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Subretinal Macugen® for Neovascular Age-Related Macular Degeneration (SUMANA)

Resource links provided by NLM:

Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: November 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00788177

Contact: Lars-Olof Hattenbach, MD +49 (621) 503 3051

Department of Ophthalmology, Ludwigshafen hospital Recruiting
Ludwigshafen, Germany, 67063
Contact: Lars-Olof Hattenbach, MD    +49 (621) 503 3051   
Principal Investigator: Lars-Olof Hattenbach, MD         
Sponsors and Collaborators
Klinikum Ludwigshafen
Principal Investigator: Lars-Olof Hattenbach, MD Department of ophthalmology, Ludwigshafen hospital
  More Information

Responsible Party: Lars-Olof Hattenbach, MD, Privatdozent, Department of ophthalmology, Ludwigshafen hospital Identifier: NCT00788177     History of Changes
Other Study ID Numbers: AU-06102G
Study First Received: November 7, 2008
Last Updated: September 26, 2011

Keywords provided by Klinikum Ludwigshafen:
age-related macular degeneration
subretinal injection

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases processed this record on May 25, 2017