The purpose of the study is to determine the effect of Intravitreal Aflibercept Injection (IAI) on previously treated Central Retinal Vein Occlusions (CRVOs) with other Anti-VEGF agents.
This prospective, open-label, single-center, nonrandomized, investigator-sponsored clinical study seeks to investigate the visual outcomes of a treat and extend dosing regimen of intravitreal aflibercept injection for macular edema following CRVO. All patients will receive IAI 2 mg at baseline and Week 4. If the pre-defined extension criteria are met at the 4-week visit, and at any follow up visit, the patient will receive a mandated treatment, and the next visit will be extended by two weeks. If the extension criteria are not met on a follow-up visit, the treatment interval will be continued to be reduced by 1 week. If criteria are still not met despite treatment at the reduced interval, treatment will be administered as usual and follow up interval will continue to be reduced by 1 week until the criteria are met or a 4-week interval is reached. Treatment of IAI is rendered at every visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intravitreal Aflibercept (2.0 mg)
Northern California Retina Vitreous Associates
Mountain View, California, United States
Duration of Intravitreal Aflibercept on Treatment Interval
Mean number of weeks between each injection where there is no macular edema
Time frame: 52 Weeks
Change in Visual Acuity
Mean change in EDTRS BCVA
Time frame: 52 Weeks
Retinal Thickness
Mean change in Central Subfoveal Thickness by OCT
Time frame: 52 Weeks
Adverse Events
Incidence and severity of ocular and systemic AE's
Time frame: 52 Weeks
Number of Treatments
Mean number of Intravitreal Injections
Time frame: 52 Weeks
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