Abstract
Purpose: :
To determine the safety and efficacy of Ranibizumab intravitreal injections in diabetic eyes with rubeosis and advanced cataracts where panretinal photocoagulation (PRP) laser is precluded due to a poor view to the fundus.
Methods: :
An ongoing prospective 2-year pilot study. Protocol involved 3 monthly intravitreal injections of Ranibizumab (0.5 mg in 0.05 mL) for rubeosis with cataract extraction after the first Ranibizumab injection. Ranibizumab injections with PRP laser were performed if rubeosis recurred or persisted after 3 months.
Results: :
Four study eyes of four diabetic subjects with rubeosis and advanced cataracts were recruited. One subject has completed the 24 month study; the average follow-up of the remaining two eyes is 8.7 months - months 13-24, however, were only for safety monitoring. Average baseline ETDRS visual acuity of the study eyes was 20/253. All four eyes received the three Ranibizumab injections per protocol and were free of rubeosis after the three injections, 3 of 4 had resolved the rubeosis after the first, with no adverse events. Rubeosis did not recur in any of the four study eyes at any point during the study. Three of four eyes required no further treatment beyond the 3 months with Ranibizumab or PRP, showed no signs of rubeosis after the first injection, or any signs of advancing proliferative disease beyond the third. No adverse events were reported for these subjects during the study. One eye, however, did show advancing proliferative disease at months 5 and 9, and received both Ranibizumab and PRP at those times. Only one of four subjects, who had a baseline history of coronary artery disease, experienced extraocular adverse events during the study period: (a) a silent MI at month 7; (b) moderate congestive heart failure at months 12 and 14; and, (c) MRSA bacteremia (from an infected foot ulcer) at month 13.
Conclusions: :
Ranibizumab may be a safe, effective, and long-lasting mode of therapy for rubeotic diabetic eyes with advanced cataracts where immediate PRP is not possible.
Clinical Trial: :
http://www.clinicaltrials.gov NCT01069341
Keywords: diabetic retinopathy • vascular endothelial growth factor • iris