Two different initial treatment regimens of ranibizumab in myopic choroidal neovascularization: 12‐month results from a randomized controlled study

Abstract

Importance:The optimal treatment regimen for myopic choroidal neovascularization (mCNV) is essential to understand but currently poorly studied. Background: To date, there is still no consensus on the optimal dosage and frequency of anti-vascular endothelial growth factor injections in treating mCNV. Design: A prospective, single-centre, single-blind, randomized controlled study. Participants: Adult patients with active mCNV. Methods: Patients were randomized 1:1 to one or three doses initial ranibizumab treatments. Additional injections were administered pro re nata (prn) over 12 mo. Main Outcome Measures: Number and frequency of injections. Results: Fifty patients participated in the study. Patients in both 1 + prn or 3 + prn groups experienced similar best-corrected visual acuity gain and anatomical improvement, including central retinal thickness (CRT), CNV thickness, area of CNV and area of leakage. Over 12 mo, patients in the 1 + prn group received fewer ranibizumab injections (2.04 AE 1.22) compared with the 3 + prn group (3.58 AE 0.72, P<0.0001), but no statistic difference of the injection received was observed in the prn period. During the follow-up, 15 of 26 eyes in the 1 + prn group and 10 of 24 eyes in the 3 + prn group received additional injections after initial dosing (P = 0.2575). Cox regression analysis showed that 1 + prn, female, age > 55 y and CRT > 300 μm are risk factors for retreatment. Conclusions and Relevance: The eyes with a single loading dose achieved parallel anatomical and functional visual improvement, while required less injections over 1 y. The risk factors for retreatment include 1 + prn, female, older age and thick retina thickness.

Beyond the Visual Acuity: Assessing the Visual Function in mCNV Patients After Anti-VEGF Treatment

“…All investigations followed the tenets of the Declaration of Helsinki. A total of 57 eyes of 57 patients with active unilateral mCNV were enrolled in this study from March 2014 to July 2018, including 20 patients who participated in a previous published study (SMILE: a single blind clinical trial “Treatment and assessment Strategy for MyopIc CNV with LucEntis: a single-center, prospective randomized controlled study,” NCT03042871) ( 14 ). The inclusion criteria were as follows: (1) unilateral active subfoveal or juxtafoveal CNV associated with high myopia (spherical equivalence < −6.0 D or axial length > 26 mm) confirmed by fundus fluorescein angiography (FFA) with a hyperfluorescent CNV network on early frames and leakage on late frames; (2) patients with baseline best-corrected visual acuity (BCVA) in the affected eye from 24 to 73 ETDRS letters; and (3) patients who received 3+prn (pro re neta) intravitreal ranibizumab treatments for 12 months.…”

“…In patients with mCNV, VA improved about 13–15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters 1 year after a scheduled anti-VEGF treatment ( 7 , 8 , 14 ). Without treatment, VA may drop to 20/200 or worse within 5 years in patients with mCNV ( 15 , 16 ).…”

Myopic choroidal neovascularization: To load or not to load

“…These features may lead to treatment requirements that are different from those that have become established for neovascular age‐related macular degeneration (nAMD) in Caucasians and also to different outcomes. The SMILE study (Treatment and assessment Strategy for MyopIc CNV with LucEntis) by Li et al of Clinical and Experimental Ophthalmology provides useful evidence to address this gap in knowledge …”

“…There was no consensus prior to the study by Li et al on whether treatment of mCNV should start with three consecutive monthly loading doses or one single initial dose. A non‐randomized prospective trial reported that bevacizumab with one initial treatment, followed by prn, achieved the same visual and anatomical outcomes with fewer injections but had a higher rate of recurrences, similar to treatment with 3‐monthly loading injections followed by prn .…”

“…The SMILE study (Treatment and assessment Strategy for MyopIc CNV with LucEntis) by Li et al of Clinical and Experimental Ophthalmology provides useful evidence to address this gap in knowledge. 1 Myopic CNV usually requires a much less intense treatment regimen than CNV in nAMD, which requires long-term injections that typically begin with an induction phase consisting of monthly injections, 2 usually at least three, followed mostly by a less intensive maintenance phase. 3 The REPAIR study administered ranibizumab using a "pragmatic treatment algorithm" after the first injection had been given for mCNV.…”