The purpose of this study is to determine whether Bevacizumab (Avastin) in combination with Dexamethasone (Ozurdex) will be effective in reducing if not eliminating the macular edema associated with the disease, central retinal vein occlusion (CRVO) in comparison to Bevacizumab (Avastin) alone.
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 and hemi vein occlusions. Until recently the standard of care for macular edema secondary to central retinal vein occlusion was observation. Recent investigations of steroids for this condition has shown greater visual benefit but is associated with risks such as cataract formation and increased intraocular pressure. 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. Bevacizumab, 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. Bevacizumab 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 steroids. Ozurdex (dexamethasone) Intravitreal Implant is a steroid injected into the eye to treat swelling that may occur when there is a blockage of certain blood vessels in your eyes. Ozurdex is also used to treat non-infectious uveitis affecting the posterior (rear) segment of the eye.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Pro re nata patients with CRVO will initially receive Bevacizumab and intravitreal Dexamethasone. And then depending on their clinical status of CRVO, Bevacizumab will be injected.
Pro re nata patients with CRVO will receive Bevacizumab. And then depending on their clinical status of CRVO, Bevacizumab will be injected.
He Eye Specialist Hospital
Shenyang, Liaoning, China
RECRUITINGMean change in monocular BCVA in the treatment eye
Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters.
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in binocular BCVA
Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters.
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in central subfield retinal thickness
Mean change in central subfield retinal thickness in the study eye, as determined by spectral domain optical coherence tomography (OCT).
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Change in Humphrey 10-2 visual field in the treatment eye
Mean deviation (MD) of the Humphrey 10-2 visual field is assessed by a Humphrey 10-2 visual field test.
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Number of Ranibizumab Treatments
Number of injections provided to the patients during the 6 month period.
Time frame: Day 1 through Month 6
Mean change in NEI VFQ25 Questionnaire Score
Scores from NEI VFQ25 questionnaire will be assessed and compared
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in VisQoL scores
Scores from VisQoL questionnaire will be assessed and compared
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Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in wavefront aberrations
Mean deviation (MD) of wavefront aberrations is assessed by Nidek OPD Scan III test
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in ocular surface and tear-film
Mean deviation (MD) of ocular surface and tear-film parameters is assessed by Oculus Keratographer test
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in vessel density
Mean deviation (MD) of vessel density is assessed by Spectralis OCT2, Heidelberg-Engineering test
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Side effects
Side effects are measured by a review of the participant's medical and ophthalmic history.
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Use of additional treatments (including laser)
Use of additional treatments (including laser) is assessed by the treating ophthalmologist
Time frame: Day 1 through Month 6
People meeting driving standards
Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.