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
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 April 16, 2014