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
Sponsor:
Collaborator:
Pfizer
Information provided by:
Klinikum Ludwigshafen
ClinicalTrials.gov Identifier:
NCT00788177
First received: November 7, 2008
Last updated: September 26, 2011
Last verified: July 2009
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ 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: 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
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788177

Contacts
Contact: Lars-Olof Hattenbach, MD +49 (621) 503 3051 hattenbl@klilu.de

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

No publications provided

Responsible Party: Lars-Olof Hattenbach, MD, Privatdozent, Department of ophthalmology, Ludwigshafen hospital
ClinicalTrials.gov Identifier: NCT00788177     History of Changes
Other Study ID Numbers: AU-06102G
Study First Received: November 7, 2008
Last Updated: September 26, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 26, 2014