Rufino Silva

Polypoidal choroidal vasculopathy and photodynamic therapy with verteporfin

BackgroundWe evaluated, in a nonrandomised, institutional, prospective study, the efficacy of photodynamic therapy (PDT) with verteporfin in age-related macular degeneration (AMD) eyes with polypoidal choroidal vasculopathy (PCV) and subfoveal exudation.MethodsA prospective clinical and angiographic study was done in 40 consecutive eyes with PCV treated with PDT using masked best-corrected visual acuity (VA) and fluorescein and indocyanine green angiographic features at baseline and over 2 years.ResultsTwenty-one eyes completed 1-year follow-up and showed, after a mean 2.9 PDT sessions, VA improvement in 12 eyes, no change in five eyes, and VA decrease in four eyes. Leakage was absent at the retinal and choroidal level in 14 eyes at 1 year. Recurrence occurred in one eye during the first year. Six eyes completed 2 years of follow-up and showed, after a mean 4 PDT sessions, VA improvement in five eyes and VA decrease in one eye. Leakage was absent at the retinal and choroidal level in five eyes. Recurrence occurred in four of these six eyes during the second year of follow-up. No serious adverse events were observed during the 2 years of follow-up.ConclusionsPDT with verteporfin was shown to be safe and effective for treating AMD eyes with PCV with subfoveal involvement. VA improvement and absence of leakage were achieved, respectively, in 57.1% and 66.6% of the eyes at 1 year. Recurrences were more frequent during the second year of follow-up.

Short-term Efficacy And Safety Of Intravitreal Ranibizumab For Myopic Choroidal Neovascularization

Purpose: To evaluate the safety and efficacy of intravitreal ranibizumab in the treatment of choroidal neovascularization (CNV) secondary to pathologic myopia (PM). Metohds: Retrospective, multicenter, consecutive, nonrandomized, interventional case series. Participants: Twenty-six eyes of 26 patients with CNV secondary to pathologic myopia; 11 eyes with previous photodynamic therapy; and 15 eyes with no previous treatment. Follow-up: 3 or more months. Best-corrected visual acuity (BCVA), ocular coherence tomography, and the presence of metamorphopsia were assessed monthly. Results: At 1 month, 31% of the eyes had an improvement in visual acuity of 3 or more lines. Twenty-six eyes completed 3 months of follow-up, and nine eyes completed 6 months of follow-up. Visual acuity improved significantly from 20/100 at baseline to 20/80 at 1 month (P = 0.003) to 20/63 at 3 months (P < 0.001), and 20/50 at 6 months (P = 0.01). A significant reduction in ocular coherence tomography central thickness was observed at 1, 3, and 6 months. No cases of severe visual acuity loss occurred, and no systemic or ocular side effects were registered during the follow-up. Conclusion: Short-term results of intravitreal ranibizumab for myopic CNV are encouraging. Further prospective long-term studies are necessary to evaluate safety and efficacy of intravitreal ranibizumab in the treatment of myopic CNV.

Intravitreal ranibizumab for myopic choroidal neovascularization: 12-month results

Purpose: The purpose of this study was to evaluate the safety and efficacy of intravitreal ranibizumab after 12 months in the treatment of choroidal neovascularization secondary to pathologic myopia. Methods: This was a prospective, multicenter, consecutive, nonrandomized, interventional case series. The study included 34 eyes of 32 patients with choroidal neovascularization secondary to pathologic myopia; 13 eyes had previous photodynamic therapy, and 21 eyes had no previous treatment. The patients were followed for ≥12 months. Best-corrected visual acuity, optical coherence tomography, and the presence of metamorphopsia were assessed monthly. Results: Mean visual acuity improved 8 letters from baseline to 12-month follow-up, and the difference was statistically significant (P < 0.001): 100% of the eyes lost <3 lines on the Early Treatment Diabetic Retinopathy Study chart, 24% of the eyes improved ≥3 lines, 44% improved ≥2 lines, 65% improved ≥1 line, and 79% improved ≥0 lines. Central retinal thickness decreased significantly from baseline to the 12-month follow-up (P < 0.01). A mean of 3.6 treatments were performed during the 12-month follow-up, and no systemic or ocular side effects were registered during that time. Conclusion: One-year results of intravitreal ranibizumab for myopic choroidal neovascularization are very promising. Additional prospective studies are necessary to better determine long-term efficacy and safety.

The SECURE study:long-term safety of Ranibizumab 0.5 mg in neovascular age-related macular degeneration

OBJECTIVE To evaluate long-term safety of intravitreal ranibizumab 0.5-mg injections in neovascular age-related macular degeneration (nAMD). DESIGN Twenty-four-month, open-label, multicenter, phase IV extension study. PARTICIPANTS Two hundred thirty-four patients previously treated with ranibizumab for 12 months in the EXCITE/SUSTAIN study. METHODS Ranibizumab 0.5 mg administered at the investigators discretion as per the European summary of product characteristics 2007 (SmPC, i.e., ranibizumab was administered if a patient experienced a best-corrected visual acuity [BCVA] loss of >5 Early Treatment Diabetic Retinopathy Study letters measured against the highest visual acuity [VA] value obtained in SECURE or previous studies [EXCITE and SUSTAIN], attributable to the presence or progression of active nAMD in the investigators opinion). MAIN OUTCOME MEASURES Incidence of ocular or nonocular adverse events (AEs) and serious AEs, mean change in BCVA from baseline over time, and the number of injections. RESULTS Of 234 enrolled patients, 210 (89.7%) completed the study. Patients received 6.1 (mean) ranibizumab injections over 24 months. Approximately 42% of patients had 7 or more visits at which ranibizumab was not administered, although they had experienced a VA loss of more than 5 letters, indicating either an undertreatment or that factors other than VA loss were considered for retreatment decision by the investigator. The most frequent ocular AEs (study eye) were retinal hemorrhage (12.8%; 1 event related to study drug), cataract (11.5%; 1 event related to treatment procedure), and increased intraocular pressure (6.4%; 1 event related to study drug). Cataract reported as serious due to hospitalization for cataract surgery occurred in 2.6% of patients; none was suspected to be related to study drug or procedure. Main nonocular AEs were hypertension and nasopharyngitis (9.0% each). Arterial thromboembolic events were reported in 5.6% of the patients. Five (2.1%) deaths occurred during the study, none related to the study drug or procedure. At month 24, mean BCVA declined by 4.3 letters from the SECURE baseline. CONCLUSIONS The SECURE study showed that ranibizumab administered as per a VA-guided flexible dosing regimen recommended in the European ranibizumab SmPC at the investigators discretion was well tolerated over 2 years. No new safety signals were identified in patients who received ranibizumab for a total of 3 years. On average, patients lost BCVA from the SECURE study baseline, which may be the result of disease progression or possible undertreatment. FINANCIAL DISCLOSURE(S) Proprietary or commercial disclosure may be found after the references.

Clinical Characteristics of Reticular Pseudodrusen in the Fellow Eye of Patients with Unilateral Neovascular Age-Related Macular Degeneration

PURPOSE To describe associations between reticular pseudodrusen, individual characteristics, and retinal function. DESIGN Cohort study. PARTICIPANTS We recruited 105 patients (age range, 52-93 years) who had advanced neovascular age-related macular degeneration (AMD) in only 1 eye from 3 clinical centers in Europe. METHODS Minimum follow-up was 12 months. The eye selected for study was the fellow eye without advanced disease. Clinical measures of vision were distance visual acuity, near visual acuity, and results of the Smith-Kettlewell low-luminance acuity test (SKILL). Fundus imaging included color photography, red-free imaging, blue autofluorescence imaging, fluorescein angiography, indocyanine green angiography, and optical coherence tomography using standardized protocols. These were used to detect progression to neovascular AMD in the study eye during follow-up. All imaging outputs were graded for the presence or absence of reticular pseudodrusen (RPD) using a multimodal approach. Choroidal thickness was measured at the foveal center and at 2 other equidistant locations from the fovea (1500 μm) nasally and temporally. Metrics on retinal thickness and volume were obtained from the manufacturer-supplied automated segmentation readouts. MAIN OUTCOME MEASURES Presence of RPD, distance visual acuity, near visual acuity, SKILL score, choroidal thickness, retinal thickness, and retinal volume. RESULTS Reticular pseudodrusen was found in 43 participants (41%) on 1 or more imaging method. The SKILL score was significantly worse in those with reticular drusen (mean score ± standard deviation [SD, 38±12) versus those without (mean score ± SD, 33±9) (P = 0.034). Parafoveal retinal thickness, parafoveal retinal volume, and all of the choroidal thickness parameters measured were significantly lower in those with reticular drusen than in those without. The presence of RPD was associated with development of neovascular AMD when corrected for age and sex (odds ratio, 5.5; 95% confidence interval, 1.1-28.8; P = 0.042). All participants in whom geographic atrophy developed during follow-up had visible RPD at baseline. CONCLUSIONS Significant differences in retinal and choroidal anatomic features, visual function, and risk factor profile exist in unilateral neovascular AMD patients with RPD compared with those without; therefore, such patients should be monitored carefully because of the risk of developing bilateral disease.

Myopic Maculopathy: A Review

Pathological myopia is a major cause of irreversible vision loss and is the fourth to ninth most frequent cause of blindness in the world. Choroidal neovascularization (CNV) secondary to pathological myopia is the leading cause of vision impairment in patients younger than 50 years. New scientific contributions have been made to the understanding of high myopia and associated CNV. New treatments have been used in recent years, and the results are still controversial. This paper is an updated review of pathological myopia – its definition and progression, epidemiology and genetics – and a review of myopic CNV including the natural history, epidemiology, risk factors, pathogenic mechanisms and treatment.

Long-Term Follow-Up of Myopic Choroidal Neovascularization Treated with Ranibizumab

Purpose: To evaluate the long-term safety and efficacy of intravitreal ranibizumab in the treatment of myopic choroidal neovascularization (CNV). Methods: Three-year retrospective, nonrandomized, interventional case series. Forty eyes of 39 patients with myopic CNV were included; 15 with previous photodynamic therapy, and 25 naïve eyes. Best-corrected visual acuity (BCVA) changes, central foveal thickness (CFT), and number of treatments were assessed, from baseline to month 36. Results: Mean visual acuity improved from 55.4 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at baseline to 59.7 letters at 12 months (p = 0.07), 61.8 letters at 24 months (p = 0.008) and 63.4 letters at 36 months (p = 0.039). Twenty-five percent of the patients gained ≧15 letters (3 lines) at 12 months, 30% at 24 months and 35% at 36 months. There was a mean reduction of 80 µm in CFT (p < 0.001). A mean of 4.1 injections were performed in the first year, 2.4 in the second year and 1.1 in the third year. Fifty-three percent of the eyes had no need for treatment during the third year of follow-up. Conclusions: Intravitreal ranibizumab seems to be an effective and safe therapeutic procedure to treat CNV in highly myopic eyes, with a high proportion of patients gaining or stabilizing BCVA at a 3-year follow-up.

Photodynamic therapy for chronic central serous chorioretinopathy.

Purpose:  This study aimed to evaluate the efficacy of photodynamic therapy (PDT) in treating chronic central serous chorioretinopathy (CSC).

Intravitreal anti-VEGF therapy for choroidal neovascularisation secondary to pathological myopia: 4-year outcome

Objective To report the visual outcome after 4-year follow-up in a series of highly myopic eyes with choroidal neovascularisation (CNV) treated with antivascular endothelial growth factor (anti-VEGF) drugs. Methods A retrospective, non-randomised, multicentre, consecutive, interventional case series study was performed. 92 highly myopic eyes with subfoveal CNV were treated with intravitreal injection (IVI) of anti-VEGF. The initial protocol (1 vs 3 injections) was dictated by surgeons’ preferences and followed by an as-needed monthly regime. Best-corrected visual acuity (BCVA) was evaluated at baseline and then monthly. The primary aim was to analyse BCVA changes. The effect of age, spherical equivalent (SE) and treating drug were evaluated as secondary objectives. Results The mean age of the patients was 57 years (SD 14, range 30–93). The mean number of letters read was 46.1 (SD 16.8, range 5–70) at baseline, 55.5 (SD 18.6, range 10–85) at 12 months, 50.1 (SD 20.1, range 5–82) at 24 months, 54.2 (SD 21.9, range 2–85) at 36 months and 53.1 (SD 22.5, range 1–83) at 48 months (p=0.000, initial vs 12, 24 and 36 months; p=0.01 initial vs 48 months; Student t test for paired data). The mean total number of IVI was 4.9 (SD 5.4, range 1–29). SE and treating drug had no influence on the final visual outcome and number of injections required. Conclusions Intravitreal bevacizumab and ranibizumab are effective therapies and show similar clinical effects in highly myopic CNV. Visual acuity gain is maintained at 4-year follow-up.

Photodynamic therapy with verteporfin in polypoidal choroidal vasculopathy: results after 3 years of follow-up.

Purpose: The purpose of this study was to evaluate the efficacy of verteporfin photodynamic therapy on the treatment of polypoidal choroidal vasculopathy. Methods: A prospective, nonrandomized institutional study was conducted involving 42 eyes of 38 patients with newly diagnosed symptomatic polypoidal choroidal vasculopathy treated exclusively with photodynamic therapy. Twenty-seven eyes completed 3 years of follow-up. Subjects were observed every 3 months with evaluation of best-corrected visual acuity (BCVA), retinography, and fluorescein and indocyanine green angiography. Treatment was given whenever the patient exhibited subfoveal exudation on fluorescein angiography. Results: Mean BCVA was 0.91 ± 0.33 logarithm of the minimum angle of resolution on the initial visit and 0.93 ± 0.39 on the 36-month visit. Patients were submitted to an average of 3.19 treatment sessions. On the final evaluation at 36 months, 14.8% of the treated eyes improved their BCVA by at least 0.3 logarithm of the minimum angle of resolution, 74.1% had no significant loss of BCVA, and 25.9% lost ≥0.3 logarithm of the minimum angle of resolution. Recurrences were frequent (59.3% of the eyes at 3 years of follow-up), responded well to retreatment, and were not associated with additional BCVA loss. Conclusion: Photodynamic therapy remains a good option for management of polypoidal choroidal vasculopathy. After 3 years, approximately three fourths of the treated eyes had no significant loss of vision, and 14.8% showed significant improvement in visual acuity.