Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate two surgical interventions in patients with AMD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 17, 2006
CompletedFirst Posted
Study publicly available on registry
November 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedSeptember 23, 2008
September 1, 2008
4.6 years
November 17, 2006
September 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Visual Acuity: distance and near
preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months
FLA
(preoperatively, 3 months, +/- 12 months after surgery)
Secondary Outcomes (4)
OCT
(preoperatively, 3 months, 12 months after surgery)
UHR OCT
(after surgery, including silicone oil removal)
autofluorescence
(preoperatively, 3 months, +/- 12 months after surgery)
perimetry
(if feasible)
Interventions
RPE cell suspension
RPE patch
Eligibility Criteria
You may qualify if:
- AMD and submacular cnv
- non responders to laser treatment or pdt
- treatment: rpe transplantation or rpe + choroid translocation
- age over 50 years
You may not qualify if:
- other additional retinal diseases, like diabetic or hypertensive retinopathy and vascular diseases.
- optic atrophy
- unstable glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Opthalmology, Rudolf Foundation Clinic
Vienna, Vienna, 1030, Austria
Related Publications (3)
van Meurs JC et al Br J opthalmol 2004; 88:110-113
BACKGROUNDvan 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.
PMID: 14516809BACKGROUNDFalkner-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.
PMID: 20610478DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susanne Binder, MD
Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology, Rudolf Foundation Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 17, 2006
First Posted
November 20, 2006
Study Start
February 1, 2004
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
September 23, 2008
Record last verified: 2008-09