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

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ClinicalTrials.gov Identifier: NCT00401713
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : September 23, 2008
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Brief Summary:
The purpose of this study is to evaluate two surgical interventions in patients with AMD.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Procedure: Transplantation of autologous RPE Procedure: Translocation of autologous RPE and Choroid Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : February 2004
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: Transplantation of autologous RPE
    RPE cell suspension
    Procedure: Translocation of autologous RPE and Choroid
    RPE patch


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

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


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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

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

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 Posted: November 20, 2006    Key Record Dates
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