Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema
Uveitic Cystoid Macular Edema (CME) is a major cause of visual loss associated with uveitis. Systemic and/or local corticosteroid therapy and systemic immunosuppression with steroid-sparing agents such as cyclosporine, methotrexate, azathioprine, or others, effectively treats uveitis and associated CME in many patients. However, in many cases, CME persists in spite of adequate suppression of uveitis. No consensus exists on how best to treat such cases. The further addition of immunosuppressive agents appears to have little effect on this form of CME. Oral corticosteroids are useful, but high dosage and prolonged use can be associated with serious side-effects. Periocular and intravitreal corticosteroid injections are associated with well-known, significant side effects such as glaucoma and cataract formation.
Vascular endothelial growth factor (VEGF) is suspected to play a role in the loss of vascular integrity in the eye and known to be induced by inflammatory cytokines, such as interleukin interleukin (IL)-1β and IL-6, which are elevated intraocularly in uveitis. In addition, it has been demonstrated that aqueous VEGF concentrations are statistically significantly higher in those uveitis patients with CME than those without CME. Inhibition of inappropriate VEGF activity is a potential approach to treatment of CME in uveitis given our current knowledge of the pathophysiology of this condition and also because of the clinical need for additional treatment options for these patients. Ranibizumab, a recombinant, humanized monoclonal antibody antigen-binding fragment (Fab) that neutralizes all active forms of VEGF-A, would target this pathway and may be useful in cases of persistent CME in uveitis patients.
The objective of this study is to determine if an anti-VEGF agent, Lucentis, is safe and effective in leading to regression of macular edema due to chronic non-infectious uveitis in patients with well-controlled uveitis.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema|
- Change From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months. [ Time Frame: 1 year ] [ Designated as safety issue: No ]Mean change in best corrected visual acuity (assessed by the ETDRS chart at 4 m) from baseline at 12 months following first intravitreal injection of ranibizumab was 12.2 ETDRS letters (P = 0.015).
- The Mean Change in Best Corrected Visual Acuity (BCVA) (Assessed by the ETDRS Chart at 4 Meters) From Baseline at 12 Months Will be Computed With a T-test. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- The Percentage of Patients With 15 Letters (3 Lines) of Visual Acuity Improvement at 30, 60, 90, 120 Days, and 12 Months. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at 30, 60, 90, 120 Days, and 12 Months Will be Computed Using a T-test. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- The Incidence of Ocular and Non-ocular Adverse Events Will be Evaluated Through Month 24. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2008|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
Other Name: Lucentis
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826618
|United States, Florida|
|Bascom Palmer Eye Insitute|
|Miami, Florida, United States, 33136|
|Bascom Palmer of the Palm Beaches|
|Palm Beach Gardens, Florida, United States, 33418|
|Principal Investigator:||Thomas A Albini, MD||University of Miami|