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Previous studies have implicated intravitreal vascular endothelial growth factor A (VEGF-A) as a target for countering neovascularization and, therefore, age-related macular degeneration. This double-blind, controlled trial comparing ranibizumab, which neutralizes all isoforms of VEGF-A, with photodynamic therapy with verteporfin showed that ranibizumab was better able to retard the progression of predominantly classic neovascular age-related macular degeneration. This trial comparing ranibizumab with photodynamic therapy with verteporfin showed that ranibizumab was better able to retard the progression of predominantly classic neovascular age-related macular degeneration. Age-related macular degeneration is a leading cause of severe and irreversible vision loss in the developed world among people 50 years of age or older. 1 – 4 The neovascular form of the disease is characterized by the growth of abnormal, choroidal blood vessels beneath the macula, which causes severe loss of vision. 5 Two main patterns of choroidal neovascularization that are associated with age-related macular degeneration, as seen on fluorescein angiography, are classic (in which intensely bright fluorescence is seen in early phases of the angiogram and leaks in late phases) and occult (in which leakage is less intense and appears in . . .

Background/aims To investigate the impact of antiangiogenic monotherapy and photodynamic therapy (PDT) as add-on strategy on retinal morphology, and to analyse prognostic biomarkers for visual outcome and retreatment frequency in neovascular age-related macular degeneration (nAMD). Methods 255 patients participating in the MONT BLANC study were evaluated. Patients were randomised to receive as-needed ranibizumab monotherapy or combination therapy (verteporfin PDT and ranibizumab). Outcome measures included visual acuity (VA), retinal morphology assessed by optical coherence tomography and retreatment frequency. Results The proportion of scans showing intraretinal cysts (IRC) or subretinal fluid (SRF) decreased more intensively in the combination than in the monotherapy group. Pigment epithelial detachments (PED) decreased significantly only in the combination group. Patients with IRC presented the lowest initial VA, and IRC had the strongest negative predictive value for functional improvement in both groups. SRF showed a predictive value for a higher number of ranibizumab injections (combination, +0.9; monotherapy, +0.8) and a higher number of PDT treatments in the combination group (+0.3). PED was associated with a higher number of ranibizumab injections only in the monotherapy group (+1.2). Conclusions Combination and monotherapy showed a distinct response pattern for morphological parameters in nAMD. IRC was the only relevant prognostic parameter for functional outcome. Trial registration number NCT00433017.

Purpose To describe screening failures in the EVEREST study by examining the imaging characteristics that enabled differentiation of polypoidal choroidal vasculopathy (PCV) from cases that were subsequently diagnosed not to be PCV. Methods Post-hoc analysis of 34 patients with PCV reported as screening failures from EVEREST study. Standardised confocal scanning laser indocyanine green angiography (ICGA) images were graded by the Central Reading Centre to confirm PCV diagnosis based on the presence of early focal sub-retinal hyperfluorescence on ICGA and at least one of the following six diagnostic criteria: (1) nodular appearance of polyp(s) on stereoscopic examination, (2) hypofluorescent halo around nodule(s), (3) presence of a branching vascular network, (4) pulsation of polyp(s) on dynamic ICGA, (5) orange sub-retinal nodules on colour fundus photography, or (6) massive sub-macular haemorrhage (≥4 disc areas in size). Additional detailed image grading was performed with stereo-imaging and dynamic early-phase ICGA. Results Of the 95 screened PCV cases, 34 were excluded: (1) cases not suitable for recruitment as per the study protocol ( n  = 14), (2) equivocal lesions on ICGA characterised by small hyperfluorescent dots ( n  = 9), and (3) cases that were definitely not PCV (non-PCV, n  = 11), identified by definitive diagnoses which included one case each of micro-aneurysm, retinal angiomatous proliferation, retino-choroidal anastomosis, small type-2 choroidal neovascularisation, retinal pigment epithelial (RPE) window defect and disciform scar; two cases of lesions where the choroidal vessel changed its course; and three cases of late-onset RPE staining. Conclusions Standardised image grading techniques used in EVEREST study enabled effective differentiation of non-PCV from actual PCV.

BACKGROUND AND OBJECTIVE: To evaluate subthreshold diode-laser micropulse (SDM) versus half-dose verteporfin photodynamic therapy (hd-PDT) in central serous chorioretinopathy (CSC). PATIENTS AND METHODS: 62 eyes of 62 patients were prospectively followed for changes in fluorescein angiography (FA), fundus autofluorescence (FAF), central macular thickness (CMT), best-corrected visual acuity (BCVA), and contrast visual acuity (CVA) after SDM (n = 20) or hdPDT (n = 24). CSC observation served as control group (n = 18). RESULTS: Both treatment groups (60% SDM vs. 66.7% hdPDT) showed significant improvement in reduction of leakage activity compared to the control group (37.5%) at 16 weeks. CMT decreased by 69.7 µm (SDM), 109.8 µm (hdPDT), and 89 µm (control). BCVA improved by +6.7 (SDM group), +8.5 (hdPDT), and +1.5 ETDRS letters (control). CVA was best improved in the hdPDT group. No secondary RPE alterations could be detected by FAF after any intervention. CONCLUSION: In comparison to the control group, hdPDT and SDM resulted in reduced leakage activity in FA and enhanced photopic and scotopic visual acuity in patients with CSC. [[ Ophthalmic Surg Lasers Imaging Retina . 2015;46:837–843.]

Purpose To evaluate the results of indocyanine green angiography (ICGA)-guided verteporfin photodynamic therapy (PDT) with half-fluence rate combined with intravitreal application of anti-VEGF in treating choroidal neovascularization (CNV) in chronic central serous chorioretinopathy (CSCR). Patients and methods In this retrospective cohort study 17 consecutive patients with secondary CNV due to chronic CSCR had their diagnosis verified with fluorescein angiography (FA) and ICGA at baseline. All eyes received either intravitreal ranibizumab (IVR) or bevacizumab (IVB). On the consecutive day following the initial IVR/IVB treatment, ICGA-guided verteporfin (6 mg/m 2 ) PDT with half-fluence rate (25 J/cm 2 ) was performed on every patient. IVR or IVB was rescheduled on a pro re nata regimen. Main outcome measures were changes in visual acuity (VA) according to the ETDRS letter score and changes in the central foveal thickness (CFT). Results Best-corrected VA at baseline was 65.6 letters (±6.7; n =17) according to the ETDRS letter score. At 12 months, mean ETDRS letter score improved to 71.2 letters ( P =0.34). CFT was 309  μ m and decreased to 216  μ m at month 12 control ( P =0.0004). Nine eyes (52.9%) received additional treatment with IVR/IVB due to recurrence of subretinal fluid, with an overall mean number of IVR/IVB treatment of 1.8±3.6 per patient with no systemic side effects during 12 months’ follow-up. Conclusions IVR or IVB combined with ICGA-guided half-fluence PDT with verteporfin is effective in treating CNV in chronic CSCR, with choroidal hyperpermeability in ICGA, resulting in stable vision and significant reduction of CFT.

Background To demonstrate the efficacy of intravitreal ranibizumab (IVR) in combination with reduced-fluence photodynamic therapy (RF-PDT) in patients with choroidal neovascularization (CNV) secondary to pathologic myopia. Methods Sixty patients affected by myopic CNV (mCNV) were randomized to receive either ranibizumab 0.5 mg monotherapy (RM; n  = 20), standard fluence PDT (SF-PDT, n  = 20) or RF-PDT combination therapy ( n  = 20). Subsequently, IVR was injected as needed. All patients were evaluated for 48 weeks. Results Mean BCVA change at 48 weeks was + 0.2 and +15 letters with SF or RFPDT plus ranibizumab, respectively, compared with +16.8 letters with RM. At 48 weeks, mean central foveal thickness (CFT) decrease from baseline was 58 ± 15 μm, 91.4 ± 43.8 μm, and 85 ± 41.5 μm for the verteporfin SF, RF and RM groups, respectively. Macular sensitivity improvement was + 0.4 db, + 1.9 dB and + 2.7 dB for the verteporfin SF, RF and RM groups, respectively. Conclusions Ranibizumab monotherapy or combined with RF-PDT improved BCVA and macular sensitivity in patients affected by mCNV, whereas CFT results were reduced. SF-PDT combination regimen mostly stabilized vision at 48 weeks. Among all groups, the RF-PDT seemed to reduce the number of ranibizumab retreatments.

Purpose: To investigate the injection frequency and visual acuity (VA) outcomes with combination therapy (ranibizumab plus verteporfin photodynamic therapy, PDT) versus monotherapy (ranibizumab). Methods: A total of 40 patients with exudative age-related macular degeneration were randomized 1:1 to ranibizumab 0.3 mg plus single standard verteporfin PDT or ranibizumab 0.3 mg plus sham PDT. Ranibizumab was administered 3 times monthly followed by ‘as needed' to month 12 based on predetermined vision/anatomical criteria. Retreatment rates, VA outcomes and safety were assessed. Results: During months 3-12, combination therapy patients required fewer ranibizumab injections (mean 1.3) compared with monotherapy patients (2.8). Mean VA improved by 9.0 letters with combination therapy versus 7.5 letters in the monotherapy group at month 12. Both treatment regimens were well tolerated. Conclusion: The need for ranibizumab retreatment might be reduced by administering a single verteporfin PDT on the same day as the first ranibizumab injection, without compromising VA outcomes or safety.

PurposeThe purpose of this study is to compare the efficacy and safety of intravitreal aflibercept (IVA) with sham photodynamic therapy (sPDT) versus IVA with verteporfin PDT (vPDT) in a Caucasian population with treatment-naive polypoidal choroidal vasculopathy (PCV), enrolling into a treat and extend (T&E) regimen.Methods and analysisRandomised, double-masked, sham-controlled, multicentre phase 4 investigator-driven clinical trial. The primary outcomes are (1) change in best-corrected visual acuity (BCVA) from baseline and (2) polyp regression at week 52, assessed by indocyanine green angiography (ICGA). Fifty patients with treatment-naive PCV will be recruited from Portuguese and Spanish clinical sites. Eligible patients will receive monthly IVA for 3 months (week 0, week 4 and week 8). At week 16, all patients will repeat ICGA and undergo central randomisation (1:1 ratio) into one of the following groups: Group 1—IVA T&E + vPDT; Group 2—IVA T&E + sPDT. PDT will be performed at week 16, week 28 and week 40 in the presence of active polyps. After week 16, the presence of macular fluid on optical coherence tomography will determine the schedule of observations. When present, the interval between visits/injections will decrease 2 weeks (minimum 6 weeks). When not, the interval between visits/injections will increase 2 weeks (maximum 12 weeks). Efficacy will be evaluated based on BCVA, central retinal thickness and polyp regression. Safety parameters will include assessment of intraocular pressure, adverse events and serious adverse events.Ethics and disseminationThis study was designed and shall be implemented and reported in accordance with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guidelines for Good Clinical Practice, with applicable local regulations and with the ethical principles laid down in the Declaration of Helsinki. The study received approval from Comissão de Ética para a Investigação Clínica and Comité Ético de investigación Clínica del Hospital Universitari de Bellvitge.Trial registration numberThis study is registered under the EudraCT number: 2015-001368-20 and the ClinicalTrials.gov Identifier: NCT02495181.

To report vision and safety outcomes up to 5 years from an extension of the Treatment of Age-related Macular Degeneration with Photodynamic Therapy (TAP) Investigation evaluating verteporfin therapy in patients with subfoveal choroidal neovascularization (CNV) in age-related macular degeneration. Patients who completed the 2-year randomized, placebo-controlled portion of the TAP Investigation could participate in the open-label extension study for an additional 3 years. Patients in the study extension received open-label verteporfin therapy in the study eye, fellow eye or both eyes, irrespective of original treatment assignment to placebo or verteporfin, if leakage from CNV was evident on fluorescein angiography. Follow-up visits occurred at 3-month intervals through to month 48, with a final follow-up visit at month 60. Of the 402 verteporfin-treated patients in the randomized trials, 320 (80%) enrolled in the extension study; 193 (60%) of these completed the extension study up to 5 years. Patients received an average of approximately two treatments during the 3 years of the extension study. Seventy-seven (62%) of the 124 verteporfin-treated patients with predominantly classic lesions at baseline who enrolled in the extension completed the month 60 examination. Twenty-six (34%) of these 77 patients had lost 3 or more lines of visual acuity by month 24 and 27 (35%) had lost this amount of vision by month 60; the mean change in visual acuity from baseline was also similar at the month 24 and month 60 examinations (-1.5 and -1.6 lines, respectively). When visual acuity results were examined for all extension patients who received verteporfin at baseline, regardless of baseline lesion composition and extension study completion status, a similar pattern of visual acuity stabilization was evident. Few additional instances of infusion-related back pain or photosensitivity reactions were reported from month 24 to month 60. No additional safety issues were noted after bilateral treatment. Vision outcomes remained relatively stable from month 24 to month 60 even though the treatment rate was low during this period. The TAP Study Group identified no new safety concerns to preclude repeating verteporfin therapy as described in this study through 5 years.

Purpose The aim of this study was to evaluate the cost effectiveness of ranibizumab compared with verteporfin photodynamic therapy (vPDT) or no treatment (observation) in patients with visual impairment due to myopic choroidal neovascularization (CNV). Methods A Markov model with health states defined by best-corrected visual acuity and a 3-month cycle length was developed. It had a healthcare provider (UK National Health Service and personal social services) perspective, a lifetime time horizon, and was based on 2011 prices; future costs and health outcomes were discounted at 3.5 % per annum. Baseline characteristics were based on the phase III RADIANCE (Ranibizumab and vPDT Evaluation in Myopic CNV) study, and year 1 health-state transitions were based on this and the VIP (Verteporfin in Photodynamic Therapy) study. Extensive sensitivity analyses tested the robustness of the model. Results The lifetime cost of treating myopic CNV with ranibizumab was £12,866, whereas vPDT and observation were associated with total costs of £14,421 and £8,163, respectively. Ranibizumab treatment produced higher cumulative quality-adjusted life-years (QALYs; 12.99) than vPDT (12.60) or observation (12.45). Ranibizumab treatment was therefore dominant, with greater health gains and lower overall costs than vPDT. Ranibizumab was cost effective compared with observation, with an incremental cost-effectiveness ratio of £8,778/QALY. In the probabilistic sensitivity analysis, ranibizumab had a 100 % and 88 % probability of being cost effective compared with vPDT and observation, respectively, at a willingness-to-pay threshold of £20,000/QALY. Conclusion This study indicates that ranibizumab therapy is dominant over vPDT for the treatment of visual impairment due to CNV secondary to pathologic myopia in the UK healthcare setting and cost effective compared with observation.