ABSTRACT
To evaluate the safety of ranibizumab as a surgical adjunct during cataract surgery in patients with proliferative diabetic retinopathy [PDR] with rubeosis, and to evaluate the efficacy and adverse effects of ranibizumab in treating PDR with rubeosis. Three intravitreal injections of 0.5 mg ranibizumab were administered on day-1, months-1 and -2 with cataract surgery 6-16 days after first injection. Retreatments with ranibizumab injections and pan-retinal photocoagulation [PRP] were given if recurrence or persistence of PDR was noted between months-3 and -11. Safety observation visits occurred at months-12, -18 and -24. Primary end points were incidence and severity of adverse events [AEs] that were related to both cataract surgery and treatment of PDR with rubeosis through month -12. Of six patients screened, four [mean age 61.3 years] were enrolled. No AEs were noted with either cataract surgery or treatment of PDR. Neovascularization of iris [NVI] promptly regressed by 4 days after first ranibizumab injection, prior to cataract surgery in three of four patients [one had significantly regressed NVI by post-injection day-3 visit]; NVI was not noted in any patient at 2 weeks after first ranibizumab injection. Recurrence of rubeosis or NVA after 3 monthly injections was not observed in any. At month-12, PDR was not present when assessed clinically and by fluorescein angiogram [FA]. Only one patient developed neovascularization of disc and neovascularization elsewhere and required retreatments at months-5 and -9. Multiple intravitreal injections of ranibizumab may be a safe, effective treatment adjunct for PDR and diabetes-related rubeosis