Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema - Full Text View

Sponsors and Collaborators:	University of Miami Genentech
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00826618

Purpose

Uveitic CME is a major cause of visual loss associated with uveitis. Systemic and/or local corticosteroid therapy and systemic immunosuppression with steroid-sparing agents such as cyclosporine, methotrexate, azathioprine, or others, effectively treats uveitis and associated CME in many patients. However, in many cases, CME persists in spite of adequate suppression of uveitis. No consensus exists on how best to treat such cases. The further addition of immunosuppressive agents appears to have little effect on this form of CME. Oral corticosteroids are useful, but high dosage and prolonged use can be associated with serious side-effects. Periocular and intravitreal corticosteroid injections are associated with well-known, significant side effects such as glaucoma and cataract formation. Vascular endothelial growth factor (VEGF) is suspected to play a role in the loss of vascular integrity in the eye and known to be induced by inflammatory cytokines, such as interleukin IL-1β and IL-6, which are elevated intraocularly in uveitis. In addition, it has been demonstrated that aqueous VEGF concentrations are statistically significantly higher in those uveitis patients with CME than those without CME. Inhibition of inappropriate VEGF activity is a potential approach to treatment of CME in uveitis given our current knowledge of the pathophysiology of this condition and also because of the clinical need for additional treatment options for these patients. Ranibizumab, a recombinant, humanized monoclonal antibody antigen-binding fragment (Fab) that neutralizes all active forms of VEGF-A, would target this pathway and may be useful in cases of persistent CME in uveitis patients. The objective of this study is to determine if an anti-VEGF agent, Lucentis, is safe and effective in leading to regression of macular edema due to chronic non-infectious uveitis in patients with well-controlled uveitis.

Condition	Intervention	Phase
Uveitic Cystoid Macular Edema	Drug: ranibizumab	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by University of Miami:

Primary Outcome Measures:

Determine whether patients who receive intravitreal ranibizumab according to the study schedule have improved vision as measured by ETDRS at 4 meters. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The mean change in BCVA (assessed by the ETDRS chart at 4 meters) from baseline at 12 months will be computed with a t-test. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
The percentage of patients with 15 letters (3 lines) of visual acuity improvement at 30, 60, 90, 120 days, and 12 months. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
The mean change in foveal retinal thickness from baseline at 7 days, and at 30, 60, 90, 120 days, and 12 months will be computed using a t-test. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
The incidence of ocular and non-ocular adverse events will be evaluated through month 24. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	June 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Ranibizumab: Experimental	Drug: ranibizumab This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Age > 18 years
Non-infectious uveitis in study eye.
Stable anti-uveitis medical regimen for at least one month prior to injection and controlled uveitis in the judgment of the investigator.
Vision 20/40 or worse in study eye.
Cystoid Macular Edema (CME) on fluorescein angiography (FA)
Optical Coherence Tomography (OCT) demonstrating thickness greater than 300 microns in the central subfield.
Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography.

Only one eye will be assessed in the study. If both eyes are eligible, the investigator will determine which eye will be entered into the study.

Exclusion Criteria:

Previous intravitreal triamcinolone injection in study eye within 3 months of study injection.
Use of more than two glaucoma medicines for study eye.
Significant epiretinal membrane as judged by treating physician.
Evidence of vitreomacular traction on OCT.
Previous vitrectomy in study eye.
Pregnancy (positive pregnancy test) or lactation.
Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
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 IND trial.
Treatment for CME with intravitreal Lucentis, Macugen, or Avastin within 6 weeks prior to enrollment in this study.
Uncontrolled inflammation in the study eye.
Current vitreous hemorrhage.
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
Known allergy to any component of the study drug.
Intraocular pressure > 25 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 non-ocular 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.
No Avastin use permitted in fellow eye during study.
Unwilling or unable to follow or comply with all study related procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826618

Contacts

Contact: Thomas A Albini, MD

305-482-5006

talbini@med.miami.edu

Locations

United States, Florida
Bascom Palmer Eye Insitute	Recruiting
Miami, Florida, United States, 33136
Contact: Thomas A Albini, MD 305-482-5006 talbini@med.miami.edu
Bascom Palmer of the Palm Beaches	Recruiting
Palm Beach Gardens, Florida, United States, 33418
Contact: Thomas A Albini, MD 305-482-5006 talbini@med.miami.edu

Sponsors and Collaborators

University of Miami

Genentech

Investigators

Principal Investigator:

Thomas A Albini, MD

University of Miami

More Information

No publications provided

Responsible Party:	University of Miami ( Thomas Albini, MD )
Study ID Numbers:	FVF4148s
Study First Received:	January 20, 2009
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00826618 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Miami:

Uveitis
Cystoid Macular Edema

Study placed in the following topic categories:

Signs and Symptoms
Macular Edema
Uveitis
Eye Diseases

Retinal Degeneration
Macular Degeneration
Edema
Retinal Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Macular Edema
Eye Diseases
Retinal Degeneration

Macular Degeneration
Edema
Retinal Diseases

ClinicalTrials.gov processed this record on September 11, 2009