Safety Study in Retinal Transplantation for Retinitis Pigmentosa.

NCT00345917 | Completed Phase 2

• 1 other identifier: 20050137
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term goal is to show that retinal transplantation can help to prevent blindness and to restore eyesight in patients with the inherited disease retinitis pigmentosa.

Conditions

Retinitis Pigmentosa.

Keywords

Retinitis Pigmentosa; Retinal Transplant; Fetal Tissue; Early treatment diabetic retinopathy study; 20/200 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 instrument DEVICE

Fetal tissue. DEVICE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 retinitis pigmentosa; 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 21 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 21 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
• A tear of the retinal pigment epithelium
• Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome
• Inability to obtain photographs to document fundus condition, including difficulty with venous access
• Participating in another ophthalmic clinical trial or use of any other investigational new drugs within 12 weeks before the start of study treatment
• Intraocular surgery within the last two months or capsulotomy within the last month in the study eye
• Patient who has a history of uveitis, Coat's disease, diabetic retinopathy, glaucoma, or a cataract that prevents visualization of the posterior pole

Sponsors & Collaborators

• Radtke, Norman D., M.D.: lead
• Foundation Fighting Blindness: collaborator

Study Sites (1)

Retina Vitreous Resource Center

Louisville, Kentucky, 40217, United States

Location

Related Publications (3)

• 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: 15302656 RESULT

• 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: 11931789 RESULT

• 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: 10511047 RESULT

Related Links

• Retina Vitreous Resource Center

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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: April 11, 2012

Record last verified: 2012-04

Locations

US (1)