Safety Study in Retinal Transplantation for Dry Age Related Macular Degeneration. - Full Text View

Sponsors and Collaborators:	Ocular Transplantation National Neurovision Research Institute None
Information provided by:	Ocular Transplantation
ClinicalTrials.gov Identifier:	NCT00346060

Purpose

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	Intervention	Phase
Dry Age Related Macular Degeneration.	Device: Retinal transplantation instrument Device: Fetal tissue.	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Safety Study in Retinal Transplantation for Dry Age Related Macular Degeneration.

Further study details as provided by Ocular Transplantation:

Primary Outcome Measures:

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

Secondary Outcome Measures:

No rejection of transplant.

Estimated Enrollment:	10
Study Start Date:	February 2002
Estimated Study Completion Date:	March 2010

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.

Eligibility

Ages Eligible for Study:	55 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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346060

Contacts

Contact: Norman D. Radtke, M.D.

502-636-2823

nradtke@prodigy.net

Locations

United States, Kentucky
Retina Vitreous Resource Center	Recruiting
Louisville, Kentucky, United States, 40217
Principal Investigator: Norman D. Radtke, M.D.

Sponsors and Collaborators

Ocular Transplantation

National Neurovision Research Institute

None

Investigators

Principal Investigator:

Norman D. Radtke, M.D.

Ocular Transplantation, LLC

More Information

Retina Vitreous Resource Center This link exits the ClinicalTrials.gov site

Ocular Transplantation, LLC. This link exits the ClinicalTrials.gov site

Publications of Results:

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.

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.

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.

Study ID Numbers:	20050380
Study First Received:	June 28, 2006
Last Updated:	June 28, 2006
ClinicalTrials.gov Identifier:	NCT00346060
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ocular Transplantation:

Dry age related macular degeneration.
Retinal Transplant
Fetal Tissue
Early treatment diabetic retinopathy study
20/200 or worse.

Study placed in the following topic categories:

Diabetic Retinopathy
Eye Diseases
Retinal Degeneration

Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 14, 2009