Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids

NCT ID: NCT00846625

Last Updated: 2014-12-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-08-31

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.

Conditions

Macular Edema; Uveitis

Keywords

Biomedical research; Macular Edema; Uveitis; Ranibizumab; Steroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Ranibizumab (0.5 mg)

Group Type: EXPERIMENTAL

ranibizumab

Intervention Type: DRUG

Intravitreal injection, 0.5 mg

2

Triamcinolone (4 mg/0.1 ml)

Group Type: ACTIVE_COMPARATOR

triamcinolone

Intervention Type: DRUG

Intravitreal injection (4 mg/0.1 ml)

Interventions

triamcinolone

Intravitreal injection (4 mg/0.1 ml)

Intervention Type: DRUG

ranibizumab

Intravitreal injection, 0.5 mg

Intervention Type: DRUG

Other Intervention Names

Triescence; Lucentis

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

University of Utah

Principal Investigators

Albert T Vitale, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

John Moran Eye Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

34035

Identifier Type: -

Identifier Source: org_study_id