Age-Related Macular Degeneration
Conditions
Keywords
submacular membrane, transplantation of RPE, translocation of RPE and Choroid
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.
Interventions
PROCEDURETransplantation of autologous RPE
RPE cell suspension
PROCEDURETranslocation of autologous RPE and Choroid
RPE patch
Sponsors
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
Countries
Austria
Outcome results
None listed