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

Primary Purpose

Dry Age Related Macular Degeneration.

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Retinal transplantation instrument
Fetal tissue.
Sponsored by
Radtke, Norman D., M.D.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Age Related Macular Degeneration. focused on measuring Dry age related macular degeneration., Retinal Transplant, Fetal Tissue, Early treatment diabetic retinopathy study, 20/200 or worse.

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina Vitreous Resource Center

Outcomes

Primary Outcome Measures

Snellen
Visual acuity
Microperimetry
Goldmann visual field
Optical coherent tomography
Fluorescein angiography

Secondary Outcome Measures

No rejection of transplant.

Full Information

First Posted
June 28, 2006
Last Updated
March 12, 2014
Sponsor
Radtke, Norman D., M.D.
Collaborators
Foundation Fighting Blindness
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1. Study Identification

Unique Protocol Identification Number
NCT00346060
Brief Title
Safety Study in Retinal Transplantation for Dry Age Related Macular Degeneration.
Official Title
Safety Study in Retinal Transplantation for Dry Age Related Macular Degeneration.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radtke, Norman D., M.D.
Collaborators
Foundation Fighting Blindness

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Age Related Macular Degeneration.
Keywords
Dry age related macular degeneration., Retinal Transplant, Fetal Tissue, Early treatment diabetic retinopathy study, 20/200 or worse.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Retinal transplantation instrument
Intervention Type
Device
Intervention Name(s)
Fetal tissue.
Primary Outcome Measure Information:
Title
Snellen
Title
Visual acuity
Title
Microperimetry
Title
Goldmann visual field
Title
Optical coherent tomography
Title
Fluorescein angiography
Secondary Outcome Measure Information:
Title
No rejection of transplant.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman D. Radtke, M.D.
Organizational Affiliation
Norman D. Radtke, M.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Vitreous Resource Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15302656
Citation
Radtke ND, Aramant RB, Seiler MJ, Petry HM, Pidwell D. Vision change after sheet transplant of fetal retina with retinal pigment epithelium to a patient with retinitis pigmentosa. Arch Ophthalmol. 2004 Aug;122(8):1159-65. doi: 10.1001/archopht.122.8.1159.
Results Reference
result
PubMed Identifier
11931789
Citation
Radtke ND, Seiler MJ, Aramant RB, Petry HM, Pidwell DJ. Transplantation of intact sheets of fetal neural retina with its retinal pigment epithelium in retinitis pigmentosa patients. Am J Ophthalmol. 2002 Apr;133(4):544-50. doi: 10.1016/s0002-9394(02)01322-3.
Results Reference
result
PubMed Identifier
10511047
Citation
Radtke ND, Aramant RB, Seiler M, Petry HM. Preliminary report: indications of improved visual function after retinal sheet transplantation in retinitis pigmentosa patients. Am J Ophthalmol. 1999 Sep;128(3):384-7. doi: 10.1016/s0002-9394(99)00250-0.
Results Reference
result
PubMed Identifier
18547537
Citation
Radtke ND, Aramant RB, Petry HM, Green PT, Pidwell DJ, Seiler MJ. Vision improvement in retinal degeneration patients by implantation of retina together with retinal pigment epithelium. Am J Ophthalmol. 2008 Aug;146(2):172-182. doi: 10.1016/j.ajo.2008.04.009. Epub 2008 Jun 10.
Results Reference
result
Links:
URL
http://www.rvrc.com
Description
Retina Vitreous Resource Center

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

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