Lucentis for Macular Edema Associated With Central Retinal Vein Occlusion

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Retina Consultants
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab

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 and/or central 1mm subfield 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 pre-menopausal women not using adequate contraception.

• Participation in another ocular investigation or trial simultaneously

• Uncontrolled hypertension

• Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse)

• Significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy

• Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema

• An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of 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 (e.g. AMD, uveitis, Irvine-Gas)

• Evidence of neovascularization of the iris or retina (presence of ischemic CRVO)

• Evidence of central atrophy or fibrosis in the study eye

• 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.

• History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.