Intravitreal Aflibercept for Neovascular Polypoidal Choroidal Vasculopathy (RIVAL Trial)
United States20 participantsStarted 2014-03
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Males and females ≥ 18 years of age. Females of child bearing potential will undergo urine pregnancy testing and be required to use appropriate methods of birth control
* ICG and fluorescein angiographic characteristics consistent with active, leaking PCV with subfoveal lesions and/or subfoveal hemorrhage, lipid exudates, PED or fluid
* Best corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity at 4 meters between 20/20 - 20/400 (BCVA ETDRS letter score 85 - 20 letters in the study eye)
* Lesion Characteristics - leaking lesions consistent with PCV. (No limitations on hemorrhage, fibrosis or atrophy)
* Clear ocular media to allow for photography/angiography
* Willing and able to comply with clinic visits and study-related procedures
* Patients with bilateral disease will only be able to enroll one eye
* Provide signed informed consent
Exclusion Criteria:
* Any history of systemic Anti-VEGF therapy
* Current ocular or periocular infection
* Active intraocular inflammation
* Any comorbid condition that may decrease visual acuity
* Any patients who have had intraocular surgery within the past 30 days for any condition
* For treatment naïve patients: No prior anti-VEGF, PDT, intravitreal steroids or laser (subfoveal or non foveal)
* For previously-treated patients :
* Prior anti-VEGF (ranibizumab, bevacizumab, pegaptanib) within 30 days
* Prior IAI
* Prior PDT , transpupillary thermal therapy (TTT) or radiation within 90 days (a ma…