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

T

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Status

Completed

Conditions

Age-Related Macular Degeneration

Treatments

Procedure: Transplantation of autologous RPE
Procedure: Translocation of autologous RPE and Choroid

Study type

Interventional

Funder types

Other

Identifiers

NCT00401713
FR-01-CI-2006

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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