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.

Bilateral macular hole is a rare secondary effect of tamoxifen, a condition which is probably underdiagnosed. We describe the case of a 63-year-old woman who had received low-dose treatment with tamoxifen for 10 years. She presented with a best-corrected visual acuity of 20/40 in both eyes and bilateral macular hole with posterior hyaloid attachment. No reflective deposits were observed. A 23-gauge pars plana vitrectomy with internal limiting membrane peeling and gas tamponade was performed in the right eye with no anatomical or functional improvement. The most accepted mechanism of macular hole related to tamoxifen is Müller cell toxicity with retinal tissue loss. Therefore, it seems that the standard procedure used in idiopathic macular hole is not the optimal choice, due to a different pathogenic mechanism.

This case report describes the intraretinal integration of a human amniotic membrane plug as a complication of macular hole repair surgery.