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OpenTrials
Completed

NCT Number: NCT00401713

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Opthalmology, Rudolf Foundation Clinic

Vienna, State of Vienna, 1030, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transplantation of autologous RPE

Procedure

RPE cell suspension

Translocation of autologous RPE and Choroid

Procedure

RPE patch

Primary outcomes

  1. Visual Acuity: distance and near

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

  2. FLA

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

Secondary outcomes

  1. OCT

    Time frame: (preoperatively, 3 months, 12 months after surgery)

  2. UHR OCT

    Time frame: (after surgery, including silicone oil removal)

  3. autofluorescence

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

  4. perimetry

    Time frame: (if feasible)

Sponsors and collaborators

Lead sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Other

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Nov 20, 2006
Registry last updated
Sep 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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