NCT00846625

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

February 18, 2009

Last Update Submit

December 9, 2014

Conditions

Macular EdemaUveitis

Keywords

Biomedical researchMacular EdemaUveitisRanibizumabSteroids

Outcome Measures

Primary Outcomes (1)

  • Ocular adverse events

    12 months

Secondary Outcomes (1)

  • Resolution of macular edema by OCT measurement

    3, 6 and 12 months

Study Arms (2)

1

EXPERIMENTAL

Ranibizumab (0.5 mg)

Drug: ranibizumab

2

ACTIVE COMPARATOR

Triamcinolone (4 mg/0.1 ml)

Drug: triamcinolone

Interventions

triamcinoloneDRUG

Intravitreal injection (4 mg/0.1 ml)

Also known as: Triescence
2
ranibizumabDRUG

Intravitreal injection, 0.5 mg

Also known as: Lucentis
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Macular EdemaUveitis

Interventions

TriamcinoloneRanibizumab

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesUveal Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Albert T Vitale, MD

    University of Utah

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

December 11, 2014

Record last verified: 2014-12

Locations

US(1)