Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids (SURFING)

Utah System of Higher Education (USHE)

Status and phase

Withdrawn

Phase 2

Conditions

Uveitis

Macular Edema

Treatments

Drug: triamcinolone

Drug: ranibizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00846625

34035

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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