Lucentis for Inflammatory Macular Edema Trial

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT00498355
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Cytoid Macular Edema
  • Uveitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.

Study Details

Uveitis is an inflammation (swelling and irritation) inside the eye, affecting the uvea. The uvea is the layer of the eye between the sclera and the retina and provides most of the blood supply to the retina. Uveitis is an important cause of visual loss. There are 30,000 new cases of legal blindness each year due to uveitis in the U.S. Sight-threatening complications associated with uveitis include macular edema, which may persist even when inflammation is controlled. The only current treatment for cystoid macular edema (CME) in uveitis patients is oral or regional steroid injections. For patients who don't respond to steroids or who are unable to tolerate steroid therapy, there are no other medical treatments. The aim of this study is to determine if ranibizumab, an FDA-approved treatment for neovascular age-related macular degeneration, is an effective treatment for those patients with uveitis-induced CME who are unable to be treated with or non-responsive to steroids.

Key Dates

First listed
Jul 10, 2007
Start date
Jul 31, 2007
Status verified
Oct 2017
Primary completion
Jan 31, 2009
Completion
Dec 31, 2009

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab
    0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.

Primary Outcome Measure

The Mean Change at 3 Months in BSCVA From Baseline [ Time Frame: baseline and 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Proctor Foundation, UCSFSan FranciscoCalifornia94143-

Find similar trials in San Francisco, CA

By research site
Proctor Foundation, UCSF· San Francisco, CA

Related Studies