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

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ClinicalTrials.gov Identifier: NCT00346060
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : March 13, 2014
Sponsor:
Collaborator:
Foundation Fighting Blindness
Information provided by (Responsible Party):
Radtke, Norman D., M.D.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Age Related Macular Degeneration. Device: Retinal transplantation instrument Device: Fetal tissue. Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Study in Retinal Transplantation for Dry Age Related Macular Degeneration.
Study Start Date : February 2002
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Snellen
  2. Visual acuity
  3. Microperimetry
  4. Goldmann visual field
  5. Optical coherent tomography
  6. Fluorescein angiography

Secondary Outcome Measures :
  1. No rejection of transplant.

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346060


Locations
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United States, Kentucky
Retina Vitreous Resource Center
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
Radtke, Norman D., M.D.
Foundation Fighting Blindness
Investigators
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Principal Investigator: Norman D. Radtke, M.D. Norman D. Radtke, M.D.
More Information
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Publications of Results:

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Responsible Party: Radtke, Norman D., M.D.
ClinicalTrials.gov Identifier: NCT00346060    
Other Study ID Numbers: 20050380
First Posted: June 29, 2006    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: March 2014
Keywords provided by Radtke, Norman D., M.D.:
Dry age related macular degeneration.
Retinal Transplant
Fetal Tissue
Early treatment diabetic retinopathy study
20/200 or worse.
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases