Safety Study in Retinal Transplantation for Retinitis Pigmentosa.

Completed · Phase 2

Conditions studied: Retinitis Pigmentosa.

In brief

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.

Key facts

Study ID

NCT00345917

Run by

Radtke, Norman D., M.D.

People needed

10

Starts

2002-02-01

Expected to finish

2012-03-01

Last updated by the study team

2012-04-11

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Retina Vitreous Resource Center — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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