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

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery40 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Age-Related Macular Degeneration

Interventions

Transplantation of autologous RPEPROCEDURE

RPE cell suspension

Translocation of autologous RPE and ChoroidPROCEDURE

RPE patch

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Opthalmology, Rudolf Foundation Clinic

Vienna, State of Vienna, Austria

Outcomes

Primary Outcomes

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 Outcomes

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)

Data from ClinicalTrials.gov

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