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Age-Related Macular DegenerationNCT00401713

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

A study testing Transplantation of autologous RPE and Translocation of autologous RPE and Choroid in people with Age-Related Macular Degeneration, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-Related Macular Degeneration
What is being tested?
Transplantation of autologous RPE and Translocation of autologous RPE and Choroid
Type of treatment
Surgery or procedure
How many people
40 participants
Where
1 siteAustria
Study dates
Feb 2004to Sep 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • AMD and submacular cnv
  • non responders to laser treatment or pdt
  • treatment: rpe transplantation or rpe + choroid translocation
  • age over 50 years

Who cannot join

  • other additional retinal diseases, like diabetic or hypertensive retinopathy and vascular diseases.
  • optic atrophy
  • unstable glaucoma

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Department of Opthalmology, Rudolf Foundation Clinic

    Vienna, State of Vienna, 1030

Other trials in Austria

About this study

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

Read the 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.

Being tested
Transplantation of autologous RPE, Translocation of autologous RPE and Choroid
Keywords
submacular membrane, transplantation of RPE, translocation of RPE and Choroid
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transplantation of autologous RPEProcedure or surgery

    RPE cell suspension

  • Translocation of autologous RPE and ChoroidProcedure or surgery

    RPE patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Acuity: distance and near

    Measured: preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months

  2. FLA

    Measured: (preoperatively, 3 months, +/- 12 months after surgery)

Secondary outcomes (4)

  1. OCT

    Measured: (preoperatively, 3 months, 12 months after surgery)

  2. UHR OCT

    Measured: (after surgery, including silicone oil removal)

  3. autofluorescence

    Measured: (preoperatively, 3 months, +/- 12 months after surgery)

  4. perimetry

    Measured: (if feasible)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2006 (estimated)
  2. Study startFeb 2004
  3. Primary completionSep 2008
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00401713
Sponsor's protocol ID
FR-01-CI-2006
Status last verified
Sep 2008
First submitted
17 Nov 2006
Last updated
23 Sep 2008
Results posted
No

Publications

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

  • 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.

    PubMed 14516809

  • 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.

    PubMed 20610478

Questions about this trial

What is this clinical trial studying?

A study testing Transplantation of autologous RPE and Translocation of autologous RPE and Choroid in people with Age-Related Macular Degeneration, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Acuity: distance and near (time frame: preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00401713, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2008.

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