Purpose:
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.
Methods:
Three intravitreal injections of 0.5 mg ranibizumab were administered on day 0, month 1 and 2 with cataract surgery 6-16 days after 1st injection. Retreatments with ranibizumab injections and pan-retinal photocoagulation (PRP) were given if recurrence or persistence of PDR was noted between months 3 to 11. Safety observation visits occurred at months 12, 18 and 24. Primary end points were incidence and severity of adverse events (AE) that were related to both cataract surgery and treatment of PDR with rubeosis through month 12. Secondary end points and results are summarized in Table 1.
Results:
Of 6 patients screened, 4 (mean age 61.3) were enrolled. No AEs were noted with either cataract surgery or treatment of PDR. Neovascularization of iris (NVI) promptly regressed by 4 days after 1st ranibizumab injection, prior to cataract surgery in 3 of 4 patients (one had significantly regressed NVI by post-injection day 3 visit); NVI was not noted in any patient at 2 weeks after 1st ranibizumab injection. Recurrence of rubeosis or NVA after 3 monthly injections was not observed in any patient. At month 12, PDR was not present assessed clinically nor by fluorescein angiogram. Only 1 patient developed neovascularization of disc and neovascularization elsewhere and required retreatments at months 5 and 9.
Conclusions:
Multiple intravitreal injections of ranibizumab may be a safe, effective treatment adjunct for PDR with diabetes related rubeosis in absence of retinal traction membranes. It might serve as a more timely treatment alternative for patients with dense cataracts, which prevents them from undergoing immediate PRP, the standard therapy of PDR. Ranibizumab treatment may have further benefits of reducing bleeding complications during anterior segment surgery in a rubeotic eye.
Clinical Trial:
http://www.clinicaltrials.gov NCT01069341
Keywords: neovascularization • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • vascular endothelial growth factor