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Study of Visual Sensitivity for Patients with Retinitis Pigmentosa - (ENROLLMENT CLOSED)
The RENOIR Retinitis Pigmentosa Visual Field Sensitivity Study is a multi-center study that will look at the safety and effectiveness of Ciliary Neurotrophic Factor (CNTF) implants on vision in persons with retinitis pigmentosa (RP), Usher type II & III, and Choroideremia. The purpose
of this study is to see if CNTF implant improves visual field sensitivity of RP
patients at one year after the implant surgery.
The research is being done because there are no effective therapies for people with these retinal degenerations.
These genetic disorders affect the ability to see at night and later cause tunnel vision and loss of central vision. Retinal degenerations affect the retina, a light sensitive layer of cells in the back of the eye. Slowly over time, these cells die and cause permanent loss of vision. CNTF has been shown to be effective in retarding vision loss from photoreceptor cell death.
The Implant
One of the major challenges in the treatment of retinal diseases is to deliver
medicine to the retina which is inside the eye. One way to ensure CNTF gets to the
back of the eye is to perform an operation to place an implant directly inside the
eye which releases CNTF. 
The implant is a small (about ¼ in. long) capsule that contains human retinal pigment
epithelium cells. These cells have been given the ability to make CNTF and release
it through the capsule membrane into the surrounding fluid. Two forms of CNTF implants
will be tested, one implant releases a higher dose of CNTF and the other implant
releases a lower dose. The implants are investigational products that have not been
approved by the Food and Drug Administration (FDA) for use in the United States.
Study Schedule
The study will be conducted at 12 centers in the US and up to 60 people will be
enrolled. Study participation involves about 18 visits over 2 ½ years.
Study Procedures
Participants will receive:
- Physical examinations
- Electrocardiograms
- Lab tests
- Complete eye exam
- Fundus photography
- Optical Coherence Tomography (OCT)
- Full Field Flicker Electroretinogram (ERG)
- Visual Field Testing
Each participant joining the study who has completed initial screening and meets
the study requirements will be scheduled to have a brief surgical procedure performed
on each eye. You will receive a very small cell-filled implant in one eye and sham
(or placebo) surgery in the other eye.
Follow-up visits for repeat assessments will be required regularly to determine
if the implant being tested is safe and effective.
You must meet certain criteria to be a participant in this study:
- 18 to 65 years of age
- Diagnosed with Retinitis Pigmentosa or Usher Syndrome Type 2 or Type 3 or Choroideremia.
- Each eye has visual acuity of at least 20/63
- Medically able to undergo ophthalmic surgery
You may not participate if you:
- Have undergone lens removal or replacement recently
- Have had previous exposure to intra-ocular devices or implants
- Have glaucoma, or have uveitis or other retinal inflammatory disease
- Are immunodeficient, or are on steroids or other immunosuppressive therapies
- Have a history of malignancy, or have a history of ocular Herpes zoster
- Require insulin for diabetes
- Have been participating in other clinical studies in the past 6 months
Other inclusion and exclusion criteria apply. The study physician will review all
the criteria to see if you may qualify to join the study.
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