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

Completed · Phase 2

Conditions studied: Dry Age Related Macular Degeneration.

In brief

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.

Key facts

Study ID

NCT00346060

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

2014-03-13

Who can join

Age: 55 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 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

Where it is running

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

Full record on ClinicalTrials.gov

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