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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00846625
Recruitment Status : Withdrawn (Insufficient enrollment (no subjects were enrolled))
First Posted : February 19, 2009
Last Update Posted : December 11, 2014
Genentech, Inc.
Information provided by:
University of Utah

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.

Condition or disease Intervention/treatment Phase
Macular Edema Uveitis Drug: triamcinolone Drug: ranibizumab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Ranibizumab (0.5 mg)
Drug: ranibizumab
Intravitreal injection, 0.5 mg
Other Name: Lucentis
Active Comparator: 2
Triamcinolone (4 mg/0.1 ml)
Drug: triamcinolone
Intravitreal injection (4 mg/0.1 ml)
Other Name: Triescence

Primary Outcome Measures :
  1. Ocular adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Resolution of macular edema by OCT measurement [ Time Frame: 3, 6 and 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00846625

United States, Utah
John Moran Eye Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Genentech, Inc.
Principal Investigator: Albert T Vitale, MD University of Utah

Responsible Party: Albert T. Vitale, MD, University of Utah Identifier: NCT00846625     History of Changes
Other Study ID Numbers: 34035
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by University of Utah:
Biomedical research
Macular Edema

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action