Lucentis for Central Retinal Vein Occlusion (CRVO) - Full Text View

Sponsor:	California Retina Consultants
Collaborator:	Genentech
Information provided by:	California Retina Consultants
ClinicalTrials.gov Identifier:	NCT00406796

Purpose

The purpose of this study is to determine whether ranibizumab will be effective in reducing if not eliminating the macular edema associated with the disease, central retinal vein occlusion (CRVO).

Condition	Intervention	Phase
Central Retinal Vein Occlusion	Drug: Ranibizumab	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	FVF3565s Intravitreal Ranibizumab (rhuFab V2) in the Treatment of Macular Edema Associated With Perfused Central (CRVO) Retinal Venous Occlusive Disease

Resource links provided by NLM:

MedlinePlus related topics: Edema

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by California Retina Consultants:

Primary Outcome Measures:

The primary objective is to determine the proportion of subjects in each group ( 0.3, 0.5 mg ) gaining 15 or more letters at month 6 and 12 (ETDRS visual refraction at 4 meters) and to determine if a difference exists between the high and low dose. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the safety and tolerability of ranibizumab in the treatment of macular edema associated with CRVO in each group [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
To determine the proportion of subjects in each group gaining 15 or more letters at month 3, 6, 9 & 12 as compared to baseline (ETDRS visual refraction at 4 meters) and to determine if a statistically significant difference exists between the groups [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
Change in central retinal thickness from baseline as measured by OCT at months 3, 6, 9 and 12 [ Time Frame: 3,6,9, and 12 months ] [ Designated as safety issue: No ]
To determine the proportion of subjects in each group losing 15 or more letters at months 3,6,9,12 as compared to baseline (ETDRS visual refraction at 4 meters) and to determine if a statistically significant difference exists between the groups. [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
To determine the proportion of subjects in each group losing 30 or more letters at months 3,6,8,12 as compared to baseline (ETDRS visual refraction at 4 meters) and to determine if a statistically significant difference exists between the groups. [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
To determine if changes in best-corrected visual acuity are correlated with changes in total macular volume, center point thickness, and/or central 1mm subfield thickness. [ Time Frame: Months 1-12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2006
Study Completion Date:	October 2010
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 0.5mg Ranibizumab	Drug: Ranibizumab 0.3mg and 0.5mg dose of Ranibizumab 0.05ml administered intravitreally Other Name: Lucentis
Active Comparator: 2 0.3mg Ranibizumab	Drug: Ranibizumab 0.3mg and 0.5mg dose of Ranibizumab 0.05ml administered intravitreally Other Name: Lucentis

Detailed Description:

Retinal Venous Occlusive disease is the second only to diabetic retinopathy as a major cause of blindness associated with retinal vascular disease. Macular edema is a major cause of vision loss in patients presenting with central abd hemi vein occlusions. Currently, there is no proven treatment to address macular edema in these patients. In the past laser photocoagulation has been used, but was found to offer no visual benefits over the natural history in the treatment of macular edema associated with CRVO. Investigators have demonstrated in case reports that intravitreal triamcinolone (Kenalog) may result in the reduction in macular edema, leading to visual improvement in some patients with CRVO. Triamcinolone is relatively well tolerated in many patients, but its use is associated with significant risk of elevated intraocular pressure, cataract, and intraocular infection.

Ranibizumab (rhuFab V2, an anti-VEGF agent, is a potent inhibitor of vascular permeability, with the potential to reduce retinal vascular leakage and diminish macular edema. In addition, as an anti-VEGF agent, it may also inhibit neovascularization of the iris, a frequent complication of ischemic central retinal vein occlusion. Ranibizumab use as an intravitreal agent does carry the risk of intraocular infection but probably carries very low risk of glaucoma or cataract formation, making it a potentially safer pharmacologic treatment for CRVO associated macular edema as compared to triamcinolone

Eligibility

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

Criteria

Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age > 18 years
Clinical evidence of perfused central retinal vein occlusion. A central retinal vein occlusion (CRVO) is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head.
Central macular edema present on clinical examination and OCT testing with a central point thickness > 250 microns
Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol.
Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography

Exclusion Criteria:

Pregnancy (positive pregnancy test) or known to be pregnant, also premenopausal women not using adequate contraception.
Participation in another simultaneous ocular investigation or trial
Patient with uncontrolled hypertension
Patient has a condition that, in the opinion of the investigator would preclude participation in the study (i.e. chronic alcoholism, drug abuse)
Patient has significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy
Exam or OCT reveals evidence of vitreoretinal interface abnormality that may be contributing to the macular edema
Eye that in the investigator has no chance of improvement in visual acuity following resolution of macular edema (i.e subretinal fibrosis or geographic atrophy)
Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (i.e AMD, uveitis, Irvine-Gas)
Evidence of neovascularization of the iris or retina (presence of ischemic CRVO)
Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.
History of Grid/Focal laser or Panretinal laser in the study eye
History of vitreous surgery in the study eye
History of use of intravitreal, peribulbar, or retrobulbar steroids within six months of the study.
History of Cataract Surgery within 6 months of enrollment.
History of YAG capsulotomy within 2 months of the surgery.
Visual acuity <20/400 in the fellow eye
Uncontrolled Glaucoma, pressure >30 despite treatment with glaucoma medications.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406796

Locations

United States, California
California Retina Consultants
Bakersfield, California, United States, 93309
California Retina Consultants
Oxnard, California, United States, 93030
California Retina Consultants
Santa Barbara, California, United States, 93103
California Retina Consultants
Santa Maria, California, United States, 93454

Sponsors and Collaborators

California Retina Consultants

Genentech

Investigators

Principal Investigator:

Dante J Pieramici, M.D.

California Retina Consultants

More Information

No publications provided

Responsible Party:	Dante J Pieramici, California Retina Consultants and Research Foundation
ClinicalTrials.gov Identifier:	NCT00406796 History of Changes
Other Study ID Numbers:	FVF3565s
Study First Received:	November 29, 2006
Last Updated:	December 2, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis

Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2012