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Safety Study in Retinal Transplantation for Dry Age Related Macular Degeneration.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00346060
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : March 13, 2014
Foundation Fighting Blindness
Information provided by (Responsible Party):
Radtke, Norman D., M.D.

Tracking Information
First Submitted Date  ICMJE June 28, 2006
First Posted Date  ICMJE June 29, 2006
Last Update Posted Date March 13, 2014
Study Start Date  ICMJE February 2002
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2006)
  • Snellen
  • Visual acuity
  • Microperimetry
  • Goldmann visual field
  • Optical coherent tomography
  • Fluorescein angiography
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00346060 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2006)
No rejection of transplant.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety Study in Retinal Transplantation for Dry Age Related Macular Degeneration.
Official Title  ICMJE Safety Study in Retinal Transplantation for Dry Age Related Macular Degeneration.
Brief Summary The long-term goal is to show that retinal transplantation can help to prevent blindness and to restore eyesight in patients with dry age related macular degeneration.
Detailed Description

The aim of this clinical trial is to test the safety of transplanting human fetal neural retinal tissue and retinal pigment epithelium into the eyes of human patients with age-related macular degeneration. Vision in the eye to be operated on will be the poorer vision of both eyes and must be 20/200 or worse. "Retinal tissue", the layers in the back of the eye, consists of neural retina and retinal pigment epithelium. "Neural retina" is the nerve cell layer that processes light into vision. The "photoreceptor cells" in the neural retina detect the light and transform it into electrical signals, which are then transferred to the brain by other retinal cells. "Retinal pigment epithelium" (RPE) is the layer behind the neural retina which helps both to nourish the cells of the neural retina and also to get rid of waste products. The fetal tissues used in this study will be derived from dead fetuses in the first 9-16 weeks of pregnancy obtained from elective abortions.

Fetal retinal transplantation is highly experimental. The research will be conducted in accordance with the prohibitions regarding the use of human fetal tissue described in Public Law 103-43, section 498B. There will be no compensation for the donor. The research will be conducted in accordance with any applicable Federal, State and local laws.

First, the technical application of the implantation instrument and its safety in the transplantation will be demonstrated in patients with 20/200 vision in one eye or worse, with functional acuity in the contra lateral eye.

Secondly, the human fetal retinal tissue will be placed in the areas beneath the retina where presently the patient has atrophy of the retinal pigment epithelium and poor retinal function.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dry Age Related Macular Degeneration.
Intervention  ICMJE
  • Device: Retinal transplantation instrument
  • Device: Fetal tissue.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2006)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject must have decreased central visual acuity of 20/200 or worse in one eye by ETDRS vision testing for a duration of at least one year in the operated eye and have the diagnosis of age related macular degeneration; vision in the nonoperated eye must be better than the operated eye. Vision in the operated eye cannot be better than 20/200.
  • Subject is older than 55 years of age
  • Patient is willing to return for follow-up visits
  • Patient has signed informed consent for retinal transplantation
  • Patient has undergone microperimetry and Goldmann visual field testing.

Exclusion Criteria:

  • Patient having a central visual acuity of better than 20/200 in one eye by ETDRS or vision worse than 20/200 in one eye by ETDRS for a duration of less than one year
  • Unwilling to sign an informed consent
  • Patient under 55 years of age
  • Patient having medical problems that are contraindicatory for short-term anesthesia
  • Patient unwilling to return for follow-up visits
  • The patient has been determined to be pregnant by patient history or by pregnancy testing in women of childbearing potential
  • Features of any condition other than age-related macular degeneration in the study eye (such as pathologic myopia or presumed ocular histoplasmosis) associated with choroidal neovascularization
  • Any significant ocular disease (other than choroidal neovascularization) that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome.
  • Inability to obtain photographs to document choroidal neovascularization, including difficulty with venous access
  • History of choroidal neovascularization in the study eye
  • Participating in another ophthalmic clinical trial or use of any other investigational new drugs within 12 weeks before the start of study treatment
  • Prior photodynamic therapy or Macugen therapy for choroidal neovascularization
  • Patient who has a history of uveitis, Coat's disease, diabetic retinopathy, glaucoma, or a cataract that prevents visualization of the posterior pole
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00346060
Other Study ID Numbers  ICMJE 20050380
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radtke, Norman D., M.D.
Study Sponsor  ICMJE Radtke, Norman D., M.D.
Collaborators  ICMJE Foundation Fighting Blindness
Investigators  ICMJE
Principal Investigator: Norman D. Radtke, M.D. Norman D. Radtke, M.D.
PRS Account Radtke, Norman D., M.D.
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP