Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 11:21 PM
Study NCT ID:
NCT00346060
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2006-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study in Retinal Transplantation for Dry Age Related Macular Degeneration.
Sponsor:
Radtke, Norman D., M.D.
Organization:
Study Overview
Official Title:
Safety Study in Retinal Transplantation for Dry Age Related Macular Degeneration.
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: