Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD - Full Text View

Sponsored by:	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Information provided by:	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:	NCT00401713

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

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD

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 ] [ Designated as safety issue: Yes ]
FLA [ Time Frame: (preoperatively, 3 months, +/- 12 months after surgery) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

OCT [ Time Frame: (preoperatively, 3 months, 12 months after surgery) ] [ Designated as safety issue: Yes ]
UHR OCT [ Time Frame: (after surgery, including silicone oil removal) ] [ Designated as safety issue: Yes ]
autofluorescence [ Time Frame: (preoperatively, 3 months, +/- 12 months after surgery) ] [ Designated as safety issue: Yes ]
perimetry [ Time Frame: (if feasible) ] [ Designated as safety issue: Yes ]

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:

RPE cell suspension

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

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
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

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

Responsible Party:	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery ( Univ Prof Dr Susanne Binder )
Study ID Numbers:	FR-01-CI-2006
Study First Received:	November 17, 2006
Last Updated:	September 21, 2008
ClinicalTrials.gov Identifier:	NCT00401713
Health Authority:	Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

submacular membrane
transplantation of RPE
translocation of RPE and Choroid

Study placed in the following topic categories:

Macular degeneration
Eye Diseases
Retinal Degeneration

Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on February 11, 2009