Lucentis for Inflammatory Macular Edema Trial

NCT00498355 | Completed Phase 1 Results DMC

• 1 other identifier: FVF3872s
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uveitis; Cytoid Macular Edema

Keywords

uveitis; cytoid macular edema; steroid; Lucentis

Outcome Measures

Primary Outcomes (1)

• The Mean Change at 3 Months in BSCVA From Baseline

  The outcome measure was mean best spectacle-corrected visual acuity (BSCVA). In this study, BSCVA was measured after trial frame manifest refraction, using high-contrast modified Bailey-Lovie (ETDRS) charts at 4 meters. The charts were placed in a retro-illuminated light box equipped with two 20-watt fluorescent tubes. The highest attainable 4-meter visual acuity score is 100 letters.

  baseline and 3 months

Secondary Outcomes (4)

• The Median Change in Best Corrected Visual Acuity From 6 to12 Months

  6 to 12 months

• The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12

  7 days, and at months 3, 6, 9, and 12

• The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous)

  Study duration

• The Incidence of Ocular and Non-ocular Adverse Events

  Study duration

Study Arms (1)

Ranibizumab

EXPERIMENTAL

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.

Drug: Ranibizumab

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.

Also known as: Lucentis

Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age ≥ 18 years
• A history of non-infectious uveitis with chronic cystoid macular edema (\> 3 months duration)
• Foveal retinal thickness of ≥ 300 µM by OCT testing
• One prior trial of oral or regional steroid treatment for CME ≥ 30 days prior to study enrollment with persistent CME (≥ 300 µM foveal retinal thickness on OCT) or inability to use steroid injections due to a history of increased IOP above 30 mmHg thought to be due to topical steroid treatment or prior steroid injections
• Anterior chamber and vitreous inflammation at the trace or below level according to the standardized classification of inflammation
• BCVA at 4 m using the ETDRS chart of 20/40 to 20/400 (Snellen equivalent) in the study eye
• Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography

You may not qualify if:

• Pregnancy (positive pregnancy test) or known to be pregnant, or premenopausal but not using adequate contraception
• Treatment for CME with oral or steroid injections, Macugen, or Avastin within 6 weeks prior to enrollment in this study. Study subjects will be allowed to continue their immunomodulatory treatment for uveitis throughout the study.
• Previous vitrectomy
• Active intraocular inflammation in the study eye (greater than trace anterior chamber or vitreous cells)
• Current vitreous hemorrhage
• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
• Known allergy to any component of the study drug
• Intraocular pressure \> 30 mm Hg despite treatment with glaucoma medications
• Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, the subject can become eligible.
• Major surgery planned during the next 6 months
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Participation in another simultaneous medical investigation or trial
• Unwilling or unable to follow or comply with all study related procedures

Sponsors & Collaborators

• University of California, San Francisco: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Proctor Foundation, UCSF

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Uveitis

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Limitations of the study include a small sample size and lack of a control group.

Results Point of Contact

• Title: Dr. Nisha Acharya
• Organization: University of California San Francisco

nisha.acharya@ucsf.edu

415-476-8131

Study Officials

• Nisha Acharya, MD MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2007
• First Posted: July 10, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 30, 2017
• Results First Posted: September 21, 2012

Record last verified: 2017-10

Locations

US (1)