Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD

Age-Related Macular Degeneration Clinical Trial

Official title:

Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401713
• Other study ID #: FR-01-CI-2006
• Status: Completed
• Phase: N/A
• First received: November 17, 2006
• Last updated: September 21, 2008
• Start date: February 2004
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Procedure:
• Transplantation of autologous RPE
RPE cell suspension
• Translocation of autologous RPE and Choroid
RPE patch

Locations

Country	Name	City	State
Austria	Department of Opthalmology, Rudolf Foundation Clinic	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Country where clinical trial is conducted

Austria, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity: distance and near		preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months	Yes
Primary	FLA		(preoperatively, 3 months, +/- 12 months after surgery)	Yes
Secondary	OCT		(preoperatively, 3 months, 12 months after surgery)	Yes
Secondary	UHR OCT		(after surgery, including silicone oil removal)	Yes
Secondary	autofluorescence		(preoperatively, 3 months, +/- 12 months after surgery)	Yes
Secondary	perimetry		(if feasible)	Yes