A Study to Evaluate the Safety of CNTO 2476 in Patients With Advanced Retinitis Pigmentosa.
The main purpose of this study is to assess the effects (good and bad) of a therapy called CNTO 2476 for patients with advanced retinitis pigmentosa. Nine patients will have CNTO 2476 injected by the surgeon into the subretinal space in the back of one of their eyes. The patients will then be assessed over a period of at least one year by their surgeon.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Open Label Non-comparative Study Evaluating the Safety of a Single, Unilateral, Subretinal Administration of CNTO 2476 in Advanced Retinitis Pigmentosa|
- Assessment of safety and patients' immune rejection throughout the trial
- Evaluation of changes from baseline in retinal structure and visual function measured throughout the course of the trial.
|Study Start Date:||April 2007|
CNTO 2476 is a type of therapy that may have beneficial effects on the retina in subjects with retinitis pigmentosa. This study will assess the safety of CNTO 2476 in patients with advanced retinitis pigmentosa. The study will also evaluate any changes in vision that might result from the injection of CNTO 2476. Nine patients with advanced retinitis pigmentosa will take part in this first study. There are two phases to this study: the main (acute) phase and the long-term safety follow-up phase. Patient participation in the main phase of the study will last approximately 12 months from the time the patient is eligible to enter the study. During the main part of the study, the patient will have a screening (or baseline visit) and if the patient is eligible for the study, the patient's doctor will then schedule the procedure for the treatment. The patient will be asked to return to the clinic approximately 4 times in the first month after the treatment (Days 1, 7 and 15 and Week 4 post-treatment). Thereafter, the visits become less frequent at Months 3, 6 and 12 post-treatment. The long-term safety follow-up phase of the trial will begin after the patient completes the main phase of the study and will last approximately 4 additional years. The clinic visits during the safety follow-up stage are only twice per year for that phase. The total length of the patient's participation in the trial could last up to 5 years (including both the main and safety follow-up phases). Patient's will receive one dose of 100 microliters CNTO 2476 as an injection into the eye.