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

Primary Purpose

Age-Related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Transplantation of autologous RPE
Translocation of autologous RPE and Choroid
Sponsored by
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring submacular membrane, transplantation of RPE, translocation of RPE and Choroid

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Opthalmology, Rudolf Foundation Clinic

Outcomes

Primary Outcome Measures

Visual Acuity: distance and near
FLA

Secondary Outcome Measures

OCT
UHR OCT
autofluorescence
perimetry

Full Information

First Posted
November 17, 2006
Last Updated
September 21, 2008
Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT00401713
Brief Title
Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD
Official Title
Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
submacular membrane, transplantation of RPE, translocation of RPE and Choroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Transplantation of autologous RPE
Intervention Description
RPE cell suspension
Intervention Type
Procedure
Intervention Name(s)
Translocation of autologous RPE and Choroid
Intervention Description
RPE patch
Primary Outcome Measure Information:
Title
Visual Acuity: distance and near
Time Frame
preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months
Title
FLA
Time Frame
(preoperatively, 3 months, +/- 12 months after surgery)
Secondary Outcome Measure Information:
Title
OCT
Time Frame
(preoperatively, 3 months, 12 months after surgery)
Title
UHR OCT
Time Frame
(after surgery, including silicone oil removal)
Title
autofluorescence
Time Frame
(preoperatively, 3 months, +/- 12 months after surgery)
Title
perimetry
Time Frame
(if feasible)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Binder, MD
Organizational Affiliation
Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology, Rudolf Foundation Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Opthalmology, Rudolf Foundation Clinic
City
Vienna
ZIP/Postal Code
1030
Country
Austria

12. IPD Sharing Statement

Citations:
Citation
van Meurs JC et al Br J opthalmol 2004; 88:110-113
Results Reference
background
PubMed Identifier
14516809
Citation
van Meurs JC, Van Den Biesen PR. Autologous retinal pigment epithelium and choroid translocation in patients with exudative age-related macular degeneration: short-term follow-up. Am J Ophthalmol. 2003 Oct;136(4):688-95. doi: 10.1016/s0002-9394(03)00384-2.
Results Reference
background
PubMed Identifier
20610478
Citation
Falkner-Radler CI, Krebs I, Glittenberg C, Povazay B, Drexler W, Graf A, Binder S. Human retinal pigment epithelium (RPE) transplantation: outcome after autologous RPE-choroid sheet and RPE cell-suspension in a randomised clinical study. Br J Ophthalmol. 2011 Mar;95(3):370-5. doi: 10.1136/bjo.2009.176305. Epub 2010 Jul 7.
Results Reference
derived

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

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