Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids

Macular Edema Clinical Trial

— SURFING  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00846625
• Other study ID #: 34035
• Status: Withdrawn
• Phase: Phase 2
• First received: February 18, 2009
• Last updated: December 9, 2014
• Start date: November 2009
• Est. completion date: August 2011

Study information

• Verified date: December 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Uveitis

Intervention

Drug:
• triamcinolone
Intravitreal injection (4 mg/0.1 ml)
• ranibizumab
Intravitreal injection, 0.5 mg

Locations

Country	Name	City	State
United States	John Moran Eye Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular adverse events		12 months	Yes
Secondary	Resolution of macular edema by OCT measurement		3, 6 and 12 months	No