NCT00346060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

10.1 years

First QC Date

June 28, 2006

Last Update Submit

March 12, 2014

Conditions

Dry Age Related Macular Degeneration.

Keywords

Dry age related macular degeneration.Retinal TransplantFetal TissueEarly treatment diabetic retinopathy study20/200 or worse.

Outcome Measures

Primary Outcomes (6)

  • Snellen

  • Visual acuity

  • Microperimetry

  • Goldmann visual field

  • Optical coherent tomography

  • Fluorescein angiography

Secondary Outcomes (1)

  • No rejection of transplant.

Interventions

Retinal transplantation instrumentDEVICE
Fetal tissue.DEVICE

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Vitreous Resource Center

Louisville, Kentucky, 40217, United States

Location

Related Publications (4)

  • 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.

    PMID: 15302656RESULT

  • 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.

    PMID: 11931789RESULT

  • 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.

    PMID: 10511047RESULT

  • 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.

    PMID: 18547537RESULT

Related Links

Study Officials

  • Norman D. Radtke, M.D.

    Norman D. Radtke, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2006

First Posted

June 29, 2006

Study Start

February 1, 2002

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

US(1)