Clinical trial NCT00846625: Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Macular Edema
Uveitis
Keywords: Biomedical research
Macular Edema
Uveitis
Ranibizumab
Steroids
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2009-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ocular adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Resolution of macular edema by OCT measurement
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: John Moran Eye Center
state: Utah
Study officials:
affiliation: University of Utah
name: Albert T Vitale, MD
role: PRINCIPAL_INVESTIGATOR
References: