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

• Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery (Other)
• Overall Status: Completed
• CT.gov ID: NCT00401713
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 55
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration	Procedure: Transplantation of autologous RPE; Procedure: Translocation of autologous RPE and Choroid	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Outcome Measures

Primary Outcome Measures

1. Visual Acuity: distance and near [preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months]

2. FLA [(preoperatively, 3 months, +/- 12 months after surgery)]

Secondary Outcome Measures

1. OCT [(preoperatively, 3 months, 12 months after surgery)]

2. UHR OCT [(after surgery, including silicone oil removal)]

3. autofluorescence [(preoperatively, 3 months, +/- 12 months after surgery)]

4. perimetry [(if feasible)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Opthalmology, Rudolf Foundation Clinic	Vienna		Austria	1030

Sponsors and Collaborators

• The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Investigators

• Principal Investigator: Susanne Binder, MD, Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology, Rudolf Foundation Clinic

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.

• ClinicalTrials.gov Identifier: NCT00401713
• Other Study ID Numbers: FR-01-CI-2006
• First Posted: Nov 20, 2006
• Last Update Posted: Sep 23, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: submacular membrane; transplantation of RPE; translocation of RPE and Choroid
• Additional relevant MeSH terms: Macular Degeneration

Study Results

No Results Posted as of Sep 23, 2008