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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2008-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Age-Related Macular Degeneration

Keywords

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submacular membrane transplantation of RPE translocation of RPE and Choroid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Transplantation of autologous RPE

RPE cell suspension

Intervention Type PROCEDURE

Translocation of autologous RPE and Choroid

RPE patch

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Principal Investigators

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Susanne Binder, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology, Rudolf Foundation Clinic

Locations

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Department of Opthalmology, Rudolf Foundation Clinic

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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van Meurs JC et al Br J opthalmol 2004; 88:110-113

Reference Type BACKGROUND

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.