Intravitreal Sirolimus as Therapeutic Approach to Uveitis (SAVE-2)
|Uveitis Intermediate Uveitis Posterior Uveitis Panuveitis||Drug: Intravitreal injection 440mcg Drug: Intravitreal injection of sirolimus 880mcg||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Sirolimus as a Therapeutic Approach for Uveitis: A Phase 2, Open-label, Randomized Study to Assess the Safety, Tolerability, and Bioactivity of Two Doses of Intravitreal Injection of Sirolimus in Patients With Non-infectious Uveitis|
- Frequency of uveitic attacks as assessed by vitreous haze and cells. [ Time Frame: 6 months ]
- Incidence of adverse and serious adverse events [ Time Frame: 6 months ]Incidence, frequencey, and severity of adverse events reported during the first 6 months of the study period.
- Changes in central retinal thickness [ Time Frame: 6 months ]Improvement or worsening of macular edema compared to baseline. Development of macular edema in patients with otherwise normal macualr thickness at baseline
- Steroid sparing effect [ Time Frame: 6 months ]
Proportion of subjects with active uveitis who achieve complete or partial response to sirolimus at month 6 while discontinuing their steroid therapy.
Proportion of subjects with inactive uveitis who maintain quiscent study eyes at month 6 while discontinuing their steroid therapy.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Experimental: Group 1
Intravitreal injections of 440mcg sirolimus (low-dose monthly group)
Drug: Intravitreal injection 440mcg
Intravitreal injections of sirolimus 440mcg/20mcL at baseline and months 1, 2, 3, 4, and 5.
Experimental: Group 2
Intravitreal injections of 880mcg sirolimus (high-dose every other month group)
Drug: Intravitreal injection of sirolimus 880mcg
Intravitreal injection of 880mcg/20mcL sirolimus at baseline and months 2 and 4.
Uveitis is a condition in which certain parts of your eye become inflamed. The inflammation is usually recurrent. If the inflammation is not treated adequately, permanent damage to the eye and to the vision may occur. The inflammation can be caused by infectious or non infectious causes. The current research is being done to determine the safety and the usefulness of treatment of non-infectious uveitis using different doses of intravitreal injections of a drug called sirolimus.
Current treatment options for uveitis include oral corticosteroids and drugs that weaken the immune system of the body (i.e., immunosuppressant drugs). Treatment using oral corticosteroids, especially for long periods, may cause many undesirable side effects and complications such as high blood sugar, high blood pressure, bone weakness, obesity, stomach ulcers, abnormal hair growth, and increased risks of infection. In addition to that, in some cases, the disease cannot be controlled even with the highest dose of steroids.
Injection of steroids around and inside the eye can be used to control uveitis. However, the inflammation does not always respond to such kind of treatment. The eyes may develop high pressure and cataract with injections of steroids into the eyes or around the eyes.
On the other hand, despite their potential effectiveness, treatment with drugs that weaken the immune system may cause severe side effects. Increased risk of infection is a common side effect of all the immunosuppressant drugs. The immune system protects the body from infections. When the immune system is suppressed, infections are more likely to happen. Some of these infections are potentially dangerous. Because the immune system protects the body against some forms of cancer, immunosuppressant drugs are also associated with a slightly increased risk of cancer. For example, long-term use of immunosuppressant drugs may carry an increased risk of developing skin cancer as a result of the combination of the drugs and exposure to sunlight. The immunosuppressive drugs are very powerful and can cause serious side effects such as high blood pressure, kidney problems, and liver problems. Some side effects may not show up until years after the medicine is used.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280669
|Contact: Quan D Nguyen, MD, MScfirstname.lastname@example.org|
|Contact: Mohamed A Ibrahim, MDemail@example.com|
|United States, Nebraska|
|Truhlsen Eye Institute, University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68105|
|Contact: Quan D Ngueyn, MD, MSc firstname.lastname@example.org|
|Contact: Mohamed A. Ibrahim, MD 443 287 5822 email@example.com|
|Principal Investigator:||Quan D Nguyen, MD, MSc||Truhlsen Eye Institute, University of Nebraska Medical Center|