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

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

Study Overview

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

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1030
        • Department of Opthalmology, Rudolf Foundation Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity: distance and near
Time Frame: preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months
preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months
FLA
Time Frame: (preoperatively, 3 months, +/- 12 months after surgery)
(preoperatively, 3 months, +/- 12 months after surgery)

Secondary Outcome Measures

Outcome Measure
Time Frame
OCT
Time Frame: (preoperatively, 3 months, 12 months after surgery)
(preoperatively, 3 months, 12 months after surgery)
UHR OCT
Time Frame: (after surgery, including silicone oil removal)
(after surgery, including silicone oil removal)
autofluorescence
Time Frame: (preoperatively, 3 months, +/- 12 months after surgery)
(preoperatively, 3 months, +/- 12 months after surgery)
perimetry
Time Frame: (if feasible)
(if feasible)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susanne Binder, MD, Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology, Rudolf Foundation Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

November 17, 2006

First Submitted That Met QC Criteria

November 17, 2006

First Posted (ESTIMATE)

November 20, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2008

Last Update Submitted That Met QC Criteria

September 21, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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