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EVEREST study report 4: Fluorescein angiography features predictive of polypoidal choroidal vasculopathy.

ABSTRACT: IMPORTANCE:It is important to identify features of polypoidal choroidal vasculopathy (PCV) that differentiate it from typical neovascular age-related macular degeneration (nAMD) on various imaging modalities, including fluorescein angiography (FA). BACKGROUND:PCV was thought to be indistinguishable from nAMD using FA alone. In real-world practice, indocyanine-green angiography may often be unavailable or contraindicated. DESIGN:Analysis of FA images from a prospective, multicentre study. PARTICIPANTS:Study images of both PCV and nAMD patients from the EVEREST study. METHODS:FA features at baseline were independently graded by masked graders (fellowship-trained ophthalmologists) using standardized diagnostic algorithms. MAIN OUTCOME MEASURES:Predictive indicators (sensitivity, specificity, positive and negative predictive values) for PCV. RESULTS:Of the 95 patients screened, 61 had PCV. Of the 34 screening failures, 15 were diagnosed as nAMD. Hyperfluorescent nodules on FA were observed in 80% of patients with PCV vs 20% with nAMD (P < 0.001). Blocked fluorescence on FA, which corresponded to the presence of subretinal haemorrhage, occurred more frequently among patients with PCV vs nAMD (61.7% vs 13.3%, P = 0.001). Similarly, the leakage characteristic of occult choroidal neovascularization occurred more frequently among patients with PCV vs nAMD (95.0% vs 73.3%, P = 0.026). The positive predictive value for PCV was 94.1% for hyperfluorescent nodules, 94.9% for blocked fluorescence, 83.8% for occult choroidal neovascularization and 82.0% for pigment epithelial detachment. CONCLUSIONS AND RELEVANCE:This study demonstrated that certain FA features can be predictive of PCV and may be considered as an indication for retina specialists to perform indocyanine green angiography as confirmatory test.

SUBMITTER: Tan CS

PROVIDER: S-EPMC6767036 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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EVEREST study report 4: Fluorescein angiography features predictive of polypoidal choroidal vasculopathy.

Tan Colin S CS Ngo Wei K WK Lim Louis W LW Tan Nikolle W NW Lim Tock H TH

Clinical & experimental ophthalmology 20190210 5

<h4>Importance</h4>It is important to identify features of polypoidal choroidal vasculopathy (PCV) that differentiate it from typical neovascular age-related macular degeneration (nAMD) on various imaging modalities, including fluorescein angiography (FA).<h4>Background</h4>PCV was thought to be indistinguishable from nAMD using FA alone. In real-world practice, indocyanine-green angiography may often be unavailable or contraindicated.<h4>Design</h4>Analysis of FA images from a prospective, mult ...[more]

PMID: 30652395

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Project description:ImportanceThe use of indocyanine green angiography (ICGA) is a criterion standard for diagnosing polypoidal choroidal vasculopathy (PCV), an endemic and common cause of vision loss in Asian and African individuals that also presents in white individuals. However, the use of ICGA is expensive, invasive, and not always available at clinical centers. Therefore, knowing the value of certain features detected using fundus photography (FP), optical coherence tomography (OCT), and fluorescein angiography (FA) to diagnose PCV without ICGA could assist ophthalmologists to identify PCV when ICGA is not readily available.ObjectiveTo explore the sensitivity, specificity, and predictive accuracy of potential diagnostic features detected using FP, OCT, and FA in diagnosing PCV without ICGA.Design, setting, and participantsDeidentified images of FP alone, OCT alone, and FA alone were graded by 3 retina specialists masked to ICGA findings for potentially diagnostic features of PCV prespecified before grading compared with the criterion standard grading of 2 other retina specialists with access simultaneously to FP, OCT, FA and ICGA. Specialists graded images of 124 eyes of 120 patients presenting between January 1, 2013, and December 31, 2016, with newly identified serous or serosanguinous maculopathy who had undergone FP, OCT, FA, and ICGA before treatment at a large referral eye center in Thailand.Main outcomes and measuresSensitivity, specificity, positive predictive value, negative predictive value, and predictive accuracy from the area under the receiver operating characteristic curve (AUC).ResultsThe mean (SD) age of the patients was 57.7 (12.6) years, 52 were women, 68 were men, and the diagnosis (from ICGA) was PCV for 65 eyes (52.4%), central serous chorioretinopathy for 45 eyes (36.3%), and typical neovascular age-related macular degeneration for 12 eyes (9.7%). With the use of FP, a potential diagnostic feature for PCV was notched or hemorrhagic pigment epithelial detachment (AUC, 0.77; 95% CI, 0.70-0.85). With the use of OCT, potential diagnostic features for PCV were pigment epithelial detachment notch (AUC, 0.90; 95% CI, 0.85-0.96), sharply peaked pigment epithelial detachment (AUC, 0.86; 95% CI, 0.80-0.92), and a hyperreflective ring (AUC, 0.86; 95% CI, 0.80-0.92). When at least 2 of these 4 signs were present, the AUC was 0.93 (95% CI, 0.89-0.98), with a sensitivity of 0.95 (95% CI, 0.87-0.99), a specificity of 0.95 (95% CI, 0.82-0.97), a positive predictive value of 0.92 (95% CI, 0.83-0.97), and a negative predictive value of 0.95 (95% CI, 0.86-0.99).Conclusions and relevanceThese data suggest that the potential diagnostic features detected using FP and OCT provide high sensitivity and specificity for a diagnosis of PCV, especially when at least 2 of 4 highly suggestive signs are present.

Project description:IntroductionThe EVEREST II study previously reported that intravitreally administered ranibizumab (IVR) combined with photodynamic therapy (PDT) achieved superior visual gain and polypoidal lesion closure compared to IVR alone in patients with polypoidal choroidal vasculopathy (PCV). This follow-up study reports the long-term outcomes 6 years after initiation of the EVEREST II study.MethodsThis is a non-interventional cohort study of 90 patients with PCV from 16 international trial sites who originally completed the EVEREST II study. The long-term outcomes were assessed during a recall visit at about 6 years from commencement of EVEREST II.ResultsThe monotherapy and combination groups contained 41 and 49 participants, respectively. The change in best-corrected visual acuity (BCVA) from baseline to year 6 was not different between the monotherapy and combination groups; - 7.4 ± 23.0 versus - 6.1 ± 22.4 letters, respectively. The combination group had greater central subfield thickness (CST) reduction compared to the monotherapy group at year 6 (- 179.9 vs - 74.2 µm, p = 0.011). Fewer eyes had subretinal fluid (SRF)/intraretinal fluid (IRF) in the combination versus monotherapy group at year 6 (35.4% vs 57.5%, p = 0.032). Factors associated with BCVA at year 6 include BCVA (year 2), CST (year 2), presence of SRF/IRF at year 2, and number of anti-VEGF treatments (years 2-6). Factors associated with presence of SRF/IRF at year 6 include combination arm (OR 0.45, p = 0.033), BCVA (year 2) (OR 1.53, p = 0.046), and presence of SRF/IRF (year 2) (OR 2.59, p = 0.042).ConclusionAt 6 years following the EVEREST II study, one-third of participants still maintained good vision. As most participants continued to require treatment after exiting the initial trial, ongoing monitoring and re-treatment regardless of polypoidal lesion status are necessary in PCV.Trial registrationClinicalTrials.gov identifier, NCT01846273.

Project description:ImportancePolypoidal choroidal vasculopathy (PCV) is a major cause of visual loss worldwide, particularly in Asia, and the appropriate understanding of the structures in PCV previously described as polypoidal lesions is important for understanding their pathogenesis, diagnosis, and prognosis.ObjectiveTo report the morphologic characteristics of polypoidal lesions and their association with branching vascular networks (BVNs) in eyes with PCV using swept-source optical coherence tomographic angiography (SS-OCTA).Design, setting, and participantsThis cross-sectional observational study included 20 participants recruited from Shanghai General Hospital with a diagnosis of PCV based on the presence of focal hyperfluorescent spots on indocyanine green angiography (ICGA). Data were collected from December 1, 2017, to September 1, 2018, and analyzed from June 1 through September 30, 2018.Main outcomes and measuresPolypoidal lesions in eyes with PCV were characterized using multimodal imaging that included fundus photography, fluorescein angiography, ICGA, SS-OCT, and SS-OCTA, and the images were anatomically aligned. Subfoveal choroidal thickness was manually measured as the distance between the Bruch membrane and the sclerochoroidal interface on the SS-OCT images.ResultsOf the 20 Asian patients, 5 (25%) were women and 15 (75%) were men. The mean (SD) age was 61.1 (7.6) years, and the mean (SD) logMAR visual acuity was 0.358 (0.294) (Snellen equivalent, 20/50 [20/40]). Twenty-three eyes underwent imaging and were diagnosed with PCV. Indocyanine green angiography identified 43 polypoidal lesions, and all corresponded to the structures that appeared as clusters of tangled vessels on SS-OCTA images. In addition, SS-OCTA detected 16 tangled vascular structures not seen on ICGA. Branching vascular networks were detected on SS-OCTA imaging in all eyes, but ICGA identified BVNs in only 17 of 23 eyes (74%). Of the 43 tangled vascular structures, 40 (93%) were located at the edge of a BVN and 3 (7%) were associated with type 2 neovascularization.Conclusions and relevanceIn eyes with PCV undergoing SS-OCTA imaging, previously described polypoidal lesions may appear as tangled vascular structures associated with BVN or type 2 neovascularization. The identification of polypoidal lesions in patients with PCV as neovascular tangles rather than actual polypoidal lesions or aneurysmal dilatations may help facilitate understanding of their pathogenesis and response to treatment.

Project description:ImportanceThe 2-year efficacy and safety of combination therapy of ranibizumab administered together with verteporfin photodynamic therapy (vPDT) compared with ranibizumab monotherapy in participants with polypoidal choroidal vasculopathy (PCV) are unclear.ObjectiveTo compare treatment outcomes of ranibizumab, 0.5 mg, plus prompt vPDT combination therapy with ranibizumab, 0.5 mg, monotherapy in participants with PCV for 24 months.Design, setting, and participantsThis 24-month, phase IV, double-masked, multicenter, randomized clinical trial (EVEREST II) was conducted among Asian participants from August 7, 2013, to March 2, 2017, with symptomatic macular PCV confirmed using indocyanine green angiography.InterventionsParticipants (N = 322) were randomized 1:1 to ranibizumab, 0.5 mg, plus vPDT (combination therapy group; n = 168) or ranibizumab, 0.5 mg, plus sham PDT (monotherapy group; n = 154). All participants received 3 consecutive monthly ranibizumab injections, followed by a pro re nata regimen. Participants also received vPDT (combination group) or sham PDT (monotherapy group) on day 1, followed by a pro re nata regimen based on the presence of active polypoidal lesions.Main outcomes and measuresEvaluation of combination therapy vs monotherapy at 24 months in key clinical outcomes, treatment exposure, and safety. Polypoidal lesion regression was defined as the absence of indocyanine green hyperfluorescence of polypoidal lesions.ResultsAmong 322 participants (mean [SD] age, 68.1 [8.8] years; 225 [69.9%] male), the adjusted mean best-corrected visual acuity (BCVA) gains at month 24 were 9.6 letters in the combination therapy group and 5.5 letters in the monotherapy group (mean difference, 4.1 letters; 95% CI, 1.0-7.2 letters; P = .005), demonstrating that combination therapy was superior to monotherapy by the BCVA change from baseline to month 24. Combination therapy was superior to monotherapy in terms of complete polypoidal lesion regression at month 24 (81 of 143 [56.6%] vs 23 of 86 [26.7%] participants; P < .001). Participants in the combination group received fewer ranibizumab injections (median, 6.0 [interquartile range (IQR), 4.0-11.0]) than the monotherapy group (median, 12.0 [IQR, 7.0-17.0]) up to month 24. The combination group required a median of 2.0 (IQR, 1.0-3.0) vPDT treatments for 24 months, with 75 of 168 participants (44.6%) requiring only 1 vPDT treatment.Conclusions and relevanceThe 24-month data findings confirm that ranibizumab therapy, given as monotherapy or in combination with vPDT, is efficacious and safe for treatment of PCV. Combination therapy with vPDT added to ranibizumab achieved superior BCVA gain, increased odds of complete polypoidal lesion regression, and fewer treatment episodes compared with ranibizumab monotherapy.Trial registrationClinicalTrials.gov Identifier: NCT01846273.

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EVEREST study report 4: Fluorescein angiography features predictive of polypoidal choroidal vasculopathy.

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EVEREST study report 4: Fluorescein angiography features predictive of polypoidal choroidal vasculopathy.

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