Efficacy and Safety of a Treat-and-Extend Regimen With Aflibercept in Treatment-Naive Patients With Type 3 Neovascularization

Abstract

Purpose: To evaluate 52-week efficacy and safety of a treat-and-extend regimen of intravitreal aflibercept 2 mg on treatment-naive Type 3 neovascularization lesions. Methods: Phase IV, prospective, open-label, single-arm, multicenter trial including patients with untreated Stage I/II Type 3 neovascularization lesions and baseline best-corrected visual acuity between 78 and 23 Early Treatment Diabetic Retinopathy Study letters. Primary endpoint: mean change in best-corrected visual acuity from baseline at 52 weeks. Results: Thirty-two eyes from 32 patients were included (mean ± SD age: 78.2 ± 7.7 years, 68.8% females, baseline best-corrected visual acuity: 57.9 ± 15.4 [Snellen fraction 20/70]). Best-corrected visual acuity increased by 10.5 ± 15.9 Early Treatment Diabetic Retinopathy Study letters at Week 52 (P = 0.0001). The mean foveal and choroidal thickness decreased by 129.1 ± 80.1 µm (P < 0.0001) and 64.3 ± 96.5 (P = 0.0001), respectively. The proportion of patients with intraretinal/subretinal fluid decreased from 28 (87.5%) at baseline to 3 (11.5%) at Week 52 (P < 0.0001). Pigment epithelial detachment and lesion area showed nonsignificant changes over 52 weeks. The mean number of injections was 8.0 ± 2.0. Seven (21.9%) patients experienced treatment-related adverse events and two (6.3%) experienced serious adverse events; one (3.1%) ocular serious adverse event requiring treatment withdrawal, endophthalmitis, and one (3.1%) nonocular spontaneously resolved serious adverse event, palpitations. One (3.1%) patient experienced an APTC ATE: nonfatal stroke not related to trial treatment. Conclusion: A treat-and-extend regimen of aflibercept improves visual acuity and retinal edema in eyes with Type 3 neovascularization over 52 weeks with good tolerability.

Comparison of 24-month treatment outcomes between as-needed treatment and switching to treat-and-extend in type 3 macular neovascularization

“…In a more recent prospective clinical trial by Arias et al a mean improvement of 10.5 ETDRS letters in BCVA was noted at week 52 with a significant decrease in retinal thickness. Furthermore, the proportion of patients with intraretinal/subretinal fluid decreased from 87.5% at baseline to 11.5% at week 52 14 .…”

“…In previous studies, both the as-needed regimen 10,13 and TAE regimen 9,11,14 were effective in treating type 3 MNV. In a prospective study by Shin et al, using the as-needed regimen, a mean of 7.7 ranibizumab injections were performed during a 24 month treatment period 10 .…”

Incidence and Timing of Pigment Epithelial Detachment and Subretinal Fluid Development in Type 3 Macular Neovascularization Associated With Age-Related Macular Degeneration

“…Both the as-needed and TAE regimens are widely used treatment strategies for type 3 MNV. [15][16][17] The asneeded regimen has an advantage over TAE in minimizing unnecessary injections and subsequently decreasing the treatment burden owing to frequent injections. In addition, since approximately 19% of type 3 MNV do not reactivate after initial loading injections, 18 as-needed retreatment can be an appropriate approach for patients without lesion reactivation.…”

Intravitreal aflibercept partially reverses severe non-proliferative diabetic retinopathy in treatment-naïve patients

“…16–18 Our results demonstrated improvements in BCVA and CFT after aflibercept treatment, in agreement with the findings of the CLARITY trial that compared aflibercept with pan-retinal photocoagulation; 20,25,26 our results are also consistent with the findings of a phase IV study in which a treat-and-extend regimen of aflibercept was found to improve visual acuity and retinal edema in eyes with Type 3 neovascularization, with good tolerability over 52 weeks. 27 Previous studies showed that when an anti-VEGF treatment was administered to patients with retinal venous obstruction, the anti-VEGF group displayed delayed progression of non-perfusion areas and showed improved reperfusion, compared with the control group. 28 Importantly, our retrospective study was unable to determine causality, but its results imply that aflibercept can considerably modify DR; the findings require confirmation in future prospective studies.…”