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CompletedNCT00346060Updated Mar 13, 2014

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

A Phase 2 interventional study of Retinal transplantation instrument and Fetal tissue. in Dry Age Related Macular Degeneration., sponsored by Radtke, Norman D., M.D.. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2014-03-13.

Sponsored by Radtke, Norman D., M.D. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
55 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Dry Age Related Macular Degeneration.

Keywords

  • Dry age related macular degeneration.
  • Retinal Transplant
  • Fetal Tissue
  • Early treatment diabetic retinopathy study
  • 20/200 or worse.
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 10 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Radtke, Norman D., M.D. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Interventions

  • DeviceRetinal transplantation instrument
  • DeviceFetal tissue.
06

What researchers measure

Primary outcomes

  1. Snellen

  2. Visual acuity

  3. Microperimetry

  4. Goldmann visual field

  5. Optical coherent tomography

  6. Fluorescein angiography

Secondary outcomes

  1. No rejection of transplant.

07

Study locations

1 site
  • Retina Vitreous Resource Center
    Louisville, Kentucky 40217, United States
08

References and documents

Publications

  • 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. PubMed 15302656 ↗
  • 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. PubMed 11931789 ↗
  • 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. PubMed 10511047 ↗
  • 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. PubMed 18547537 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00346060
Lead sponsor
Radtke, Norman D., M.D.
Collaborators
Foundation Fighting Blindness
Responsible party
Sponsor
First posted
Jun 29, 2006
Start date
Feb 2002
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Mar 13, 2014

Study contacts

Norman D. Radtke, M.D.
principal investigator · Norman D. Radtke, M.D.
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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