Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to investigate the safety and efficacy of intravitreally administered ranibizumab (Lucentis) compared to steroid injection for the treatment of macular edema due to chronic non-infectious uveitis. There is currently no FDA-approved therapy for this condition, however intravitreal injection of corticosteroids, in conjunction with oral steroids and/or immunomodulatory drug agents, has become the mainstay of therapy. Ranibizumab is a recombinant monoclonal antibody antigen-binding fragment that neutralizes the active forms of vascular endothelial growth factor (VEGF), which is believed to contribute to the etiology of inflammation and neovascularization. Ranibizumab is FDA-approved for the treatment of neovascular age-related macular degeneration.

Detailed Description
-----------------
This is a proof of concept study to assess the safety and potential efficacy of ranibizumab in this patient population. Since it is common clinical practice to perform regional periocular injections of steroids in patients with uveitic macular edema, only patients who are refractory to periocular steroids will be enrolled in the study. The 0.5 mg dose of ranibizumab will be given intravitreally since this dose and route has been found to be safe and efficacious in prior studies. A dosing regimen has not been established for ranibizumab in patients with uveitis, so patients will be assessed and treated monthly as needed. Triamcinolone 4mg intravitreal injection will be the steroid treatment, and patients will also be assessed monthly and retreated every three months as needed.

Official Title
-----------------
Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids Following a Periocular Steroid Injections in Patients on Steroid Sparing Agents or Low Dose Steroids

Conditions
-----------------
Macular Edema, Uveitis

Intervention / Treatment
-----------------
* Drug: triamcinolone
* Drug: ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age History of non-infectious uveitis w chronic cystoid macular edema Refractory to therapy w periocular steroids; Last periocular steroid injection a minimum of 3 months prior to study enrollment Currently using oral steroids (< or = 10 mg/day) and/or steroid sparing agents BCVA between 20/40 and 20/400 IOP between 5 mmHg and 30 mmHg Media clarity sufficient for OCT measurement Exclusion Criteria: Women known to be pregnant or have a positive urine pregnancy test; Pre-menopausal women not using adequate contraception during the study Prior treatment for CME with Macugen or Avastin in the study eye History of stroke Presence of vitreous hemorrhage or epiretinal membrane in the study eye Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye Presence or history of uncontrolled glaucoma Known allergy or hypersensitivity to any component of the study drug Major surgery planned during the next 6 months Simultaneous participation in another clinical investigation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ranibizumab (0.5 mg) | Drug: ranibizumab<br>* Intravitreal injection, 0.5 mg<br>* Other names: Lucentis;|
| Active Comparator: 2<br>Triamcinolone (4 mg/0.1 ml) | Drug: triamcinolone<br>* Intravitreal injection (4 mg/0.1 ml)<br>* Other names: Triescence;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular adverse events |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of macular edema by OCT measurement |  | 3, 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomedical research, Macular Edema, Uveitis, Ranibizumab, Steroids