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

Primary Purpose

Macular Edema, Uveitis

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

triamcinolone

ranibizumab

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring Biomedical research, Macular Edema, Uveitis, Ranibizumab, Steroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

John Moran Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Ranibizumab (0.5 mg)

Triamcinolone (4 mg/0.1 ml)

Outcomes

Primary Outcome Measures

Ocular adverse events

Secondary Outcome Measures

Resolution of macular edema by OCT measurement

Full Information

NCT ID

NCT00846625

First Posted

February 18, 2009

Last Updated

December 9, 2014

Sponsor

University of Utah

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00846625

Brief Title

Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Insufficient enrollment (no subjects were enrolled)

Study Start Date

November 2009 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Utah

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Edema, Uveitis

Keywords

Biomedical research, Macular Edema, Uveitis, Ranibizumab, Steroids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Ranibizumab (0.5 mg)

Arm Title

Arm Type

Active Comparator

Arm Description

Triamcinolone (4 mg/0.1 ml)

Intervention Type

Drug

Intervention Name(s)

triamcinolone

Other Intervention Name(s)

Triescence

Intervention Description

Intravitreal injection (4 mg/0.1 ml)

Intervention Type

Drug

Intervention Name(s)

ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

Intravitreal injection, 0.5 mg

Primary Outcome Measure Information:

Title

Ocular adverse events

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Resolution of macular edema by OCT measurement

Time Frame

3, 6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Albert T Vitale, MD

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

Facility Information:

Facility Name

John Moran Eye Center

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

12. IPD Sharing Statement

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Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids

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