Lee-Jen Chen

EVEREST study: efficacy and safety of verteporfin photodynamic therapy in combination with ranibizumab or alone versus ranibizumab monotherapy in patients with symptomatic macular polypoidal choroidal vasculopathy.

Purpose: To assess the effects of verteporfin photodynamic therapy (PDT) combined with ranibizumab or alone versus ranibizumab monotherapy in patients with symptomatic macular polypoidal choroidal vasculopathy. Methods: In this multicenter, double-masked, primarily indocyanine green angiography–guided trial, 61 Asian patients were randomized to verteporfin PDT (standard fluence), ranibizumab 0.5 mg, or the combination. Patients were administered with verteporfin PDT/placebo and initiated with three consecutive monthly ranibizumab/sham injections starting Day 1, and re-treated (Months 3–5) as per predefined criteria. The primary endpoint was the proportion of patients with indocyanine green angiography–assessed complete regression of polyps at Month 6. Secondary endpoints included mean change in best-corrected visual acuity at Month 6 and safety. Results: At Month 6, verteporfin combined with ranibizumab or alone was superior to ranibizumab monotherapy in achieving complete polyp regression (77.8% and 71.4% vs. 28.6%; P < 0.01); mean change ± standard deviation in best-corrected visual acuity (letters) was 10.9 ± 10.9 (verteporfin PDT + ranibizumab), 7.5 ± 10.6 (verteporfin PDT), and 9.2 ± 12.4 (ranibizumab). There were no new safety findings with either drug used alone or in combination. Conclusion: Verteporfin PDT combined with ranibizumab 0.5 mg or alone was superior to ranibizumab monotherapy in achieving complete regression of polyps in this 6-month study in patients with symptomatic macular polypoidal choroidal vasculopathy. All treatments were well tolerated over 6 months.

Polypoidal choroidal vasculopathy: evidence-based guidelines for clinical diagnosis and treatment.

Background: Polypoidal choroidal vasculopathy (PCV) is an exudative maculopathy affecting vision, with clinical features distinct from neovascular age-related macular degeneration. Currently, no evidence-based guidelines exist for its diagnosis and treatment. Methods: A panel of experts analyzed a systematic literature search on PCV together with results of the EVEREST trial, the only published randomized controlled clinical trial in PCV. At a subsequent Roundtable meeting, recommendations for the management of PCV were agreed based on this analysis and their own expert opinion. Results: Diagnosis of PCV should be based on early-phase nodular hyperfluorescence from choroidal vasculature visualized using indocyanine green angiography. Recommended initial treatment of juxtafoveal and subfoveal PCV is either indocyanine green angiography-guided verteporfin photodynamic therapy or verteporfin photodynamic therapy plus 3 × 0.5 mg ranibizumab intravitreal injections 1 month apart. If there is incomplete regression of polyps by indocyanine green angiography, eyes should be retreated with verteporfin photodynamic therapy monotherapy or verteporfin photodynamic therapy plus ranibizumab. If there is complete regression of polyps by indocyanine green angiography, but there is leakage on fluorescein angiography and other clinical or anatomical signs of disease activity, eyes should be retreated with ranibizumab. Conclusion: Practical guidance on the clinical management of PCV is proposed based on expert evaluation of current evidence.

Exploring the relationship between preterm placental calcification and adverse maternal and fetal outcome.

To explore the relationship between preterm placental calcification and adverse pregnancy outcome, including maternal and fetal outcomes.

Efficacy and Safety of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial

Importance Polypoidal choroidal vasculopathy (PCV) is a common subtype of exudative age-related macular degeneration among Asian individuals. To our knowledge, there are no large randomized clinical trials to evaluate intravitreal ranibizumab, with and without verteporfin photodynamic therapy (vPDT), for the treatment of PCV. Objective To compare the efficacy and safety of combination therapy of ranibizumab and vPDT with ranibizumab monotherapy in PCV. Design, Setting, and Participants A double-masked, multicenter randomized clinical trial of 322 Asian participants with symptomatic macular PCV confirmed by the Central Reading Center using indocyanine green angiography was conducted between August 7, 2013, and March 2, 2017. Interventions Participants were randomized 1:1 to ranibizumab, 0.5 mg, and vPDT (n = 168; combination therapy group) or ranibizumab, 0.5 mg, and sham PDT (n = 154; monotherapy group). All participants received 3 consecutive monthly ranibizumab injections, followed by a pro re nata regimen. Participants also received vPDT/sham PDT on day 1, followed by a pro re nata regimen based on the presence of active polypoidal lesions. Main Outcomes and Measures Step 1 assessed whether combination therapy was noninferior (5-letter margin) to monotherapy for change in best-corrected visual acuity from baseline and superior in complete polyp regression. If noninferiority was established, step 2 assessed whether combination therapy was superior to monotherapy measured by best-corrected visual acuity change at month 12. Results Baseline demographics of the 322 participants were comparable between the treatment groups. Mean (SD) age of the patients was 68.1 (8.8) years, and overall, 69.9% of the patients were men. At baseline, the overall mean best-corrected visual acuity and mean central subfield thickness were 61.1 letters and 413.3 &mgr;m, respectively. At 12 months, mean improvement from baseline was 8.3 letters with combination therapy vs 5.1 letters with monotherapy (mean difference, 3.2 letters; 95% CI, 0.4-6.1), indicating that combination therapy met the predefined criterion for noninferiority as well as being superior to monotherapy (P = .01). Combination therapy was also superior to monotherapy in achieving complete polyp regression at month 12 (69.3% vs 34.7%; P < .001). Over 12 months, the combination therapy group received a median of 4.0 ranibizumab injections compared with 7.0 in the monotherapy group. Vitreous hemorrhage was the only ocular serious adverse event (combination therapy group, 1 [0.6%]; monotherapy group, 3 [2.0%]). Conclusions and Relevance After 12 months, combination therapy of ranibizumab plus vPDT was not only noninferior but also superior to ranibizumab monotherapy in best-corrected visual acuity and superior in complete polyp regression while requiring fewer injections. Combination therapy should be considered for eyes with PCV. Trial Registration clinicaltrials.gov Identifier: NCT01846273.

Half-Dose Verteporfin Combined with Half-Fluence Photodynamic Therapy for Chronic Central Serous Chorioretinopathy

PURPOSE This study evaluated the safety and efficacy of half-dose verteporfin combined with half-fluence photodynamic therapy (half-half photodynamic therapy (PDT) for chronic central serous chorioretinopathy (CSC). METHODS This was a retrospective case series. Fourteen eyes with chronic CSC receiving half-half PDT were included in group 1. Another 28 eyes receiving half-dose verteporfin combined with standard fluence PDT were included in group 2 as a control group. Main outcome measures were the success rates, major complications, best-corrected visual acuity (BCVA), and central subfield foveal thickness (CFT) on optical coherence tomography (OCT) at 6 months in both groups. Success of treatment was defined as complete resolution of subretinal fluid on OCT after treatment without recurrence. RESULTS There was no significant difference between groups in their age, gender, duration of symptoms, baseline BCVA, baseline CFT, PDT spot size, and follow-up duration. The success rate was 64% (9/14 eyes) in group 1 and 93% (26/28 eyes) in group 2 at 6 months (P=0.031). No major complications were found in either group. Mean CFT showed significant reduction at 6 months in both groups (-115 μm and P<0.001 in group 1; -150 μm and P<0.001 in group 2). The mean BCVA in group 2 improved significantly (P<0.001) at 6 months. The mean BCVA in group 1 showed a trend of improvement but was not statistically significant (P=0.25) at 6 months. CONCLUSIONS Half-half PDT is a feasible treatment for chronic CSC. However, there was a lower success rate at 6 months compared with the control group.

Choroidal metastasis from esophageal squamous cell carcinoma

We presented a rare case of a sole choroidal metastatic tumor from esophageal squamous cell carcinoma (ESCC) without other organ metastasis in Taiwan. A 43-year-old male with ESCC was referred for a 1-month history of decreased vision in his left eye. A 5.7 mm thick, yellow choroidal tumor occupied posterior pole, featured with pinpoint hyperfluorescence on angiography and subretinal fluid on optical coherence tomography. Positron emission tomography showed a singular hypermetabolic focus in the left eye. The tumor regressed with complete response and the vision preserved after radiation with total 57.60 gray applied by tomotherapy. The gastrointestinal system is the third most common metastatic origin in Taiwan while esophageal cancer metastasizing to choroid is rare. The discrepancy between the high prevalence of primary ESCC and the rareness of choroidal metastasis from ESCC is undetermined.

Eclipse photodynamic therapy for a presumed peripapillary metastatic tumor.

PURPOSE We report a successful use of a modified photodynamic therapy (PDT) termed Eclipse PDT in treating a patient with peripapillary metastatic choroidal tumor. METHODS Optic disk protection effect was measured with different colored paper disk attached to the reflecting mirror of the laser machine. RESULTS Black paper disk was chosen to perform Eclipse PDT because of its maximal blocking effect. A patient with peripapillary metastatic choroidal tumor was treated using this method, and the postoperative outcome was favorable, with improvement in visual acuity and resolution of subretinal fluid. CONCLUSION With the new technique, treatment can be modified according to the lesions shape and location without damaging the optic disk. Eclipse PDT can further extend the indication of PDT treatment to peripapillary choroidal neovascularization as well as choroidal tumors close to the optic disk.

Acquired Ocular Toxoplasmosis in a Patient with Sulfa Allergy-A Case Report

Purpose: To report a rare case of acquired ocular toxoplasmosis in a patient with sulfa allergy.Method: A case report.Result: We report the case of a 55- year-old woman who presented with vitritis and focal chorioretinitis in right eye without a pre-existing scar. She had higher serum titers of anti-toxoplasma immunnoglobluin (Ig)M and IgG, leading to a diagnosis of acquired ocular toxoplasmosis. Because the patient had sulfa allergy, she underwent clindamycin therapy instead for 1 month, but the ocular lesion recurred. Subsequently, she underwent combination therapy with pyrimethamine, azithromycin, folic acid and corticosteroids for 1 month. The chorioretinal lesion reduced to a pigmented scar and the best corrected visual acuity of the right eye returned to 1.0 without recurrence of ocular lesions for 6 months.Conclusion: Acquired ocular toxoplasmosis is a rare disease. Laboratory tests for anti-toxoplasma antibodies can be useful in establishing diagnosis in such cases. Sulfadiazine can be successfully replaced by azithromycin in combination therapy for patients with sulfa allergy.

Clinical and Oct Characteristics of Peripapillary Detachment in Pathologic Myopia

Purpose: To investigate the clinical and OCT characteristics of peripapillary detachment in pathologic myopia (PDPM). Methods: Medical records of patients with PDPM diagnosed from January 2006 to February 2009 were reviewed. Data analysis included sex, age, best-corrected visual acuity (BCVA), refractive error, axial length, fundoscopic and OCT findings. Results: 60 patients (90 eyes) were analyzed. There were 39 females and 21 males in this study. The mean age was 45.9±10.8 years and the mean BCVA in log MAR was 0.77±0.36. The mean refractive error in spherical equivalent (SE) was the -11.14±4.04 D and mean axial length (AL) was 28.13±1.69 mm. Indirect ophthalmoscopy revealed the presence of a typical yellow-orange, localized, well-circumscribed peripapillary lesion in 39 (43.3%) eyes with PDPM. Communication between the vitreous cavity and sub-RPE space through pit-like structure was demonstrated in 13 of 90 eyes (14.4%). Conclusion: The presence of a typical yellow-orange peripapillary retinal lesion might not be an evident fundoscopic feature for all eyes with demonstrable PDPM by optical coherence tomography. Although its pathogenesis and pathologic significance require further investigation, the peripapillary pit-like structure may play a role in the formation of PDPM.

Vitrectomy without Internal Limiting Membrane Peeling for Macular Retinoschisis in Highly Myopic Eyes

Purpose: To report the surgical outcome of vitrectomy (PPV) without internal limiting membrane (ILM) peeling in three highly myopic patients with macular retinoschisis and associated posterior staphyloma. Design: Three interventional case reports. Methods: Three highly myopic patients who had macular retinoschisis and retinal detachment underwent simple PPV without ILM peeling, and long-acting gas injection. Main outcome measures included best-corrected visual acuity (BCVA), biomicroscopic appearance, and optical coherent tomography (OCT) finding. After PPV without ILM peeling, BCVA improved in all three eyes with the median BCVA improved from CF/50cm to 0.1. OCT showed complete resolution of myopic foveal detachment in all three operated eyes for follow-up periods of at least 6 months. Conclusions: PPV and gas tamponade without ILM peeling seems to be effective for treating macular retinoschisis and foveal retinal detachment in highly myopic patients with posterior staphyloma. The visual and anatomical outcomes are comparable with previously reported studies in which ILM removal was performed.