Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema

Conditions

• Uveitic Cystoid Macular Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ranibizumab — DRUG
  This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.

Study Details

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.

Key Dates

First listed

Jan 22, 2009

Start date

Jun 30, 2008

Status verified

Aug 2014

Primary completion

Sep 30, 2012

Completion

Sep 30, 2013

Study Design

Enrollment

6 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ranibizumab

Primary Outcome Measure

Change From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months. [ Time Frame: 1 year ]

Locations (2)

Find similar trials in Miami, FL