Safety Study in Retinal Transplantation for Retinitis Pigmentosa.
Retinitis Pigmentosa.
About this trial
This is an interventional treatment trial for Retinitis Pigmentosa. focused on measuring Retinitis Pigmentosa, Retinal Transplant, Fetal Tissue, Early treatment diabetic retinopathy study, 20/200 or worse.
Eligibility Criteria
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 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. 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 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
Sites / Locations
- Retina Vitreous Resource Center