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Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00401713
First Posted: November 20, 2006
Last Update Posted: September 23, 2008
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.
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
  Purpose
The purpose of this study is to evaluate two surgical interventions in patients with AMD.

Condition Intervention
Age-Related Macular Degeneration Procedure: Transplantation of autologous RPE Procedure: Translocation of autologous RPE and Choroid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD

Resource links provided by NLM:


Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:
  • Visual Acuity: distance and near [ Time Frame: preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months ]
  • FLA [ Time Frame: (preoperatively, 3 months, +/- 12 months after surgery) ]

Secondary Outcome Measures:
  • OCT [ Time Frame: (preoperatively, 3 months, 12 months after surgery) ]
  • UHR OCT [ Time Frame: (after surgery, including silicone oil removal) ]
  • autofluorescence [ Time Frame: (preoperatively, 3 months, +/- 12 months after surgery) ]
  • perimetry [ Time Frame: (if feasible) ]

Estimated Enrollment: 40
Study Start Date: February 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Transplantation of autologous RPE
    RPE cell suspension
    Procedure: Translocation of autologous RPE and Choroid
    RPE patch
Detailed Description:
The Submacular surgical trials have shown that submacular membrane extraction alone did not improve or preserve visual acuity in patients with AMD. Transplantation of autologous RPE and translocation of autologous RPE and choroid represent two promising therapeutic interventions in patients with AMD. This prospective, randomized clinical trial compares the two surgical treatments and additionally compares the clinical results (visual acuity, FLA) with OCT- and UHR-OCT data.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AMD and submacular cnv
  • non responders to laser treatment or pdt
  • treatment: rpe transplantation or rpe + choroid translocation
  • age over 50 years

Exclusion Criteria:

  • other additional retinal diseases, like diabetic or hypertensive retinopathy and vascular diseases.
  • optic atrophy
  • unstable glaucoma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401713


Locations
Austria
Department of Opthalmology, Rudolf Foundation Clinic
Vienna, Austria, 1030
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
Principal Investigator: Susanne Binder, MD Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology, Rudolf Foundation Clinic
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Univ Prof Dr Susanne Binder, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00401713     History of Changes
Other Study ID Numbers: FR-01-CI-2006
First Submitted: November 17, 2006
First Posted: November 20, 2006
Last Update Posted: September 23, 2008
Last Verified: September 2008

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
submacular membrane
transplantation of RPE
translocation of RPE and Choroid

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