May 2007
Volume 48, Issue 13
ARVO Annual Meeting Abstract  |   May 2007
Preservation and Improvement of Vision in RP and AMD Patients by Implantation of Layers of Retinal Progenitor Cells Together With RPE - A Phase II Clinical Study
Author Affiliations & Notes
  • N. D. Radtke
    Retina Vitreous Resource Center, Louisville, Kentucky
  • M. J. Seiler
    Ophthalmology; Cell & Neurobiol., Keck Sch. Med., USC, Los Angeles, California
  • H. M. Petry
    Psychological & Brain Sci.,
    University of Louisville, Louisville, Kentucky
  • D. Pidwell
    Jewish Hospital, Louisville, Kentucky
  • R. B. Aramant
    Anat. Sci. & Neurobiol.,
    University of Louisville, Louisville, Kentucky
  • Footnotes
    Commercial Relationships N.D. Radtke, Ocular Transplantation LLC, I; M.J. Seiler, Ocular Transplantation LLC, C; Ocular Transplantation LLC, P; H.M. Petry, None; D. Pidwell, None; R.B. Aramant, Ocular Transplantation LLC, E; Ocular Transplantation LLC, P.
  • Footnotes
    Support Foundation Fighting Blindness; Private Funds; Vitreoretinal Research Foundation
Investigative Ophthalmology & Visual Science May 2007, Vol.48, 3658. doi:
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    • Get Citation

      N. D. Radtke, M. J. Seiler, H. M. Petry, D. Pidwell, R. B. Aramant; Preservation and Improvement of Vision in RP and AMD Patients by Implantation of Layers of Retinal Progenitor Cells Together With RPE - A Phase II Clinical Study. Invest. Ophthalmol. Vis. Sci. 2007;48(13):3658.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose:: To present the first results of phase II clinical trials to demonstrate the efficacy and safety of implantation of neural retinal progenitor cells with their RPE in retinitis pigmentosa (RP) and dry age-related macular degeneration (ARMD) patients.

Methods:: Using a unique instrument and procedure, layers of retina/RPE were implanted under the fovea in ten patients (6 RP, 4 ARMD) with 20/200 or worse vision (protocol following declaration of Helsinki; FDA BB-IND #8354; ID # NCT00345917, NCT00346060). Donor tissue was obtained at 11-15 weeks gestation. All donors and recipients were tissue-typed. Patients were tested pre- and postoperatively by fluorescein angiograms, SLO, mfERG, microperimetry and ETDRS with a second outside independent evaluator. No immunosuppressant drugs were given.

Results:: Of 10 patients, clinical evidence of visual improvement was seen in five (3 RP, 2 ARMD), three remained the same (1 RP, 2 ARMD), and two RP patients’ vision continued to deteriorate. All patients with EDTRS improvement also noted subjective improvements. Although no match was found between donors and recipients, no rejection of the implanted tissue was observed. No leakage on fluorescein angiograms suggested that the implanted RPE cells appeared to re-establish a new blood-retinal barrier. Microperimetry showed no improved sensitivity in the implant area in the five last patients tested. The previously reported vision improvement of RP patient EB from 20/800 to 20/200 EDTRS at two years after implantation (Radtke et al. 2004, Arch Ophthalmol, 122: 1159-1165) has been maintained for almost 5 years.

Conclusions:: The beneficial effect seen in patients with retinal degeneration, corroborated with earlier results in animal models of retinal degeneration, suggests that retinal implants could be a viable therapy in the future.

Clinical Trial:: NCT00345917, NCT00346060

Keywords: transplantation • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • retina 

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