University of Illinois Chicago
The purpose of the study is to determine if anti-VEGF/anti-Ang2 therapy results in prevention of vitreous hemorrhage or retinal detachment as compared to localized scatter laser photocoagulation in patients with stage 3 Proliferative sickle retinopathy (PSR) and to determine if anti-VEGF therapy results in significant clearing of vitreous hemorrhage and faster improvement of visual acuity as compared to observation
This is a phase 3 randomized, controlled, open-label, multicenter clinical trial with 5 to 6 sites in the United States that will enroll up to a total of 50 patients with stage 3 and 4 of Proliferative sickle retinopathy (PSR). There will be a maximum of 30 stage 4 eyes and a minimum of 20 stage 3 eyes
Inclusion Criteria: * Signed Informed Consent Form * Ability to comply with the study protocol * Ability and willingness to undertake all scheduled visits and assessments * Age 18 years at the time of providing informed consent * Sickle cell hemoglobinopathy with active seafans with or without prior laser treatment * Visual acuity \> 20/40 / \> 70 letters on ETDRS chart) for stage 3 * Visual acuity of 20/40 or worse (\< 58 letters) for stage 4 PSR and no known prior retinal disease that could explain the visual acuity impairment aside from PSR with vitreous hemorrhage. * Ocular inclusion crit…
Injection of faricimab 6mg in 0.05 ml intravitreally into the sickle cell eye stage 3 or stage 4
pars plana vitrectomy for stage 4 that does not clear by month 4
laser to the retina
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