Clinical trial NCT00401713: Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD
Official title: Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Macular Degeneration
Keywords: submacular membrane
transplantation of RPE
translocation of RPE and Choroid
Lead sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor class: OTHER
First posted: 2006-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Acuity: distance and near
timeFrame: preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months
measure: FLA
timeFrame: (preoperatively, 3 months, +/- 12 months after surgery)
Secondary outcomes:
measure: OCT
timeFrame: (preoperatively, 3 months, 12 months after surgery)
measure: UHR OCT
timeFrame: (after surgery, including silicone oil removal)
measure: autofluorescence
timeFrame: (preoperatively, 3 months, +/- 12 months after surgery)
measure: perimetry
timeFrame: (if feasible)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Opthalmology, Rudolf Foundation Clinic
Study officials:
affiliation: Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology, Rudolf Foundation Clinic
name: Susanne Binder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Meurs JC et al Br J opthalmol 2004; 88:110-113
citation: 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.
citation: 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.