- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00401713
Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD
September 21, 2008 updated by: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
The purpose of this study is to evaluate two surgical interventions in patients with AMD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
General Publications
- van Meurs JC, ter Averst E, Hofland LJ, van Hagen PM, Mooy CM, Baarsma GS, Kuijpers RW, Boks T, Stalmans P. Autologous peripheral retinal pigment epithelium translocation in patients with subfoveal neovascular membranes. Br J Ophthalmol. 2004 Jan;88(1):110-3. doi: 10.1136/bjo.88.1.110.
- 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.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- FR-01-CI-2006
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.
Clinical Trials on Age-Related Macular Degeneration
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationChina
-
Hoffmann-La RocheWithdrawnNeovascular Age-Related Macular DegenerationDenmark, Argentina, Hong Kong, Thailand, Portugal, Greece, Spain
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationSpain, Italy, Germany, Canada, Ireland
-
Novartis PharmaceuticalsTerminatedNeovascular Age-Related Macular Degeneration
-
Regeneron PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States
-
Ocular Therapeutix, Inc.Duke University; FortreaRecruitingNeovascular Age-Related Macular DegenerationUnited States
-
Innostellar Biotherapeutics Co.,LtdRecruitingNeovascular Age-Related Macular DegenerationChina
-
Ocular Therapeutix, Inc.CompletedNeovascular Age-Related Macular DegenerationUnited States
-
Novartis PharmaceuticalsWithdrawn
-
Apellis Pharmaceuticals, Inc.CompletedNeovascular Age-Related Macular DegenerationUnited States, Australia
Clinical Trials on Transplantation of autologous RPE
-
National Eye Institute (NEI)RecruitingGeographic Atrophy | Dry Age-Related Macular DegenerationUnited States
-
Beijing Tongren HospitalRecruitingMacular DegenerationChina
-
Southern Medical University, ChinaCellonis Biotechnology Co. Ltd.; The Second People's Hospital of Nanhai District... and other collaboratorsCompletedStroke | Infarction, Middle Cerebral ArteryChina
-
Chaitanya Hospital, PuneUnknown
-
Royan InstituteHazrat Fatemeh HospitalCompletedEpidermolysis Bullosa With Mitten HandsIran, Islamic Republic of
-
Chaitanya Hospital, PuneUnknown
-
Boston Children's HospitalRecruitingExtracorporeal Membrane Oxygenation ComplicationUnited States
-
Arda KianiRoyan InstituteUnknownEmphysemaIran, Islamic Republic of
-
Chaitanya Hospital, PuneUnknown
-
BioCardia, Inc.CompletedMyocardial Infarction | Ventricular DysfunctionArgentina