Safety Study in Retinal Transplantation for Retinitis Pigmentosa.

This study has been completed.
Sponsor:
Collaborator:
Foundation Fighting Blindness Clinical Research Institute
Information provided by (Responsible Party):
Radtke, Norman D., M.D.
ClinicalTrials.gov Identifier:
NCT00345917
First received: June 28, 2006
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

The long-term goal is to show that retinal transplantation can help to prevent blindness and to restore eyesight in patients with the inherited disease retinitis pigmentosa.


Condition Intervention Phase
Retinitis Pigmentosa.
Device: Retinal transplantation instrument
Device: Fetal tissue.
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Study in Retinal Transplantation for Retinitis Pigmentosa.

Resource links provided by NLM:


Further study details as provided by Radtke, Norman D., M.D.:

Primary Outcome Measures:
  • Snellen
  • Visual acuity
  • Microperimetry
  • Goldmann visual field
  • Optical coherent tomography
  • Fluorescein angiography

Secondary Outcome Measures:
  • No rejection of transplant.

Enrollment: 10
Study Start Date: February 2002
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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 retinitis pigmentosa. 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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 retinitis pigmentosa; 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 21 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 21 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
  • A tear of the retinal pigment epithelium
  • Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome
  • Inability to obtain photographs to document fundus condition, including difficulty with venous access
  • Participating in another ophthalmic clinical trial or use of any other investigational new drugs within 12 weeks before the start of study treatment
  • Intraocular surgery within the last two months or capsulotomy within the last month in the study eye
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345917

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

Additional Information:
Publications:
Responsible Party: Radtke, Norman D., M.D.
ClinicalTrials.gov Identifier: NCT00345917     History of Changes
Other Study ID Numbers: 20050137
Study First Received: June 28, 2006
Last Updated: April 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Radtke, Norman D., M.D.:
Retinitis Pigmentosa
Retinal Transplant
Fetal Tissue
Early treatment diabetic retinopathy study
20/200 or worse.

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 30, 2014