Intravitreal Ranibizumab 0.5MG, or 1.0mg for RVO With Macular Edema Previously Receiving Bevacizumab



Status:Completed
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:November 2011
End Date:June 2013
Contact:Thomas O'Hearn, MD
Email:tohearn@gmail.com
Phone:310-829-3303

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Phase I/II, Open-label, Study of Intravitreal RAnibizumab 0.5MG, or High Dose 1.0mg for Retinal Vein Occlusions With rEfractory Macular Edema Previously Receiving iNtravitreal Bevacizumab (RAVEN)

This study examines two doses of Ranibizumab (0.5mg and 1.0mg) for the treatment of macular
edema secondary to retinal vein occlusion in patients that have previously failed treatment
with other macular edema treatments including bevacizumab.


Inclusion Criteria:

- Ability to provide written informed consent and comply with study assessments for the
full duration of the study

- Age > 18 years

- CRVO or BRVO diagnosis

- For CRVO, clinical evidence of perfused central retinal vein occlusion. A 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 > 300 microns after at least 3
months of bevacizumab or steroid therapy.

- 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.

- Patients must demonstrate that they are no longer improving on bevacizumab or
intravitreal steroid therapy (i.e. no improvement in acuity in 2 consecutive visits)

- BRVO patients treated with grid laser must show residual edema three months following
latest laser treatment

- 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

- 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

- 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 or severe epiretinal membrane)

- 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/BRVO)

- 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 in the previous
three months

- History of vitreous surgery in the study eye

- History of use of intravitreal, peribulbar, or retrobulbar steroids within three
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.
We found this trial at
4
sites
Huntington Beach, California 92647
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Long Beach, California 90807
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Santa Monica, California 90404
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Santa Monica, CA
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Torrance, California 90505
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Torrance, CA
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