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

This study has been terminated.
(Insufficient enrollment (no subjects were enrolled))
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00846625
First received: February 18, 2009
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Macular Edema
Uveitis
Drug: triamcinolone
Drug: ranibizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Ocular adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Resolution of macular edema by OCT measurement [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846625

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

No publications provided

Responsible Party: Albert T. Vitale, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00846625     History of Changes
Other Study ID Numbers: 34035
Study First Received: February 18, 2009
Last Updated: August 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
Biomedical research
Macular Edema
Uveitis
Ranibizumab
Steroids

Additional relevant MeSH terms:
Edema
Macular Edema
Uveitis
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
Uveal Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014