Dataset Information

Nonresponders to Ranibizumab Anti-VEGF Treatment Are Actually Short-term Responders: A Prospective Spectral-Domain OCT Study.

ABSTRACT: Purpose: To investigate the inter-individual variability in duration of anti-vascular endothelial growth factor (VEGF) treatment effect in neovascular age-related macular degeneration (nvAMD).

Design: Prospective observational multi-centered study.

Participants: Forty-eight patients with nvAMD treated with anti-VEGF injections were included. Both treatment naive (n=25) as well as patients who had previously received treatment with ranibizumab (n=23) more than one month prior to their enrollment were recruited.

Methods: Patients received injection with ranibizumab (0.5 mg/0.05 ml) and were followed weekly for 4 weeks with spectral-domain OCT (SD-OCT) assessing the time to maximal reduction of central retinal thickness (CRT) and the presence of intraretinal and subretinal fluid. Other data collected included age, gender, visual acuity, axial length, lens status, and previous injections. The Shapiro-Wilk test was used to examine normal distributions for all variables. Correlations were examined by calculating Spearman's correlation coeficient. Distributions of quantitative variables are described as means (±SD). Qualitative variables are summarized by counts and percentage.

Main outcome measures: Time to maximal reduction of CRT and intra- and subretinal fluid after ranibizumab injection.

Results: A total of 48 eyes of 48 patients (age 74.8±8.3 years, 62.5% female, 52% treatment naive, 35.4% pseudophakic) were assessed. Two-thirds (64.6%) reached maximal CRT reduction earlier than the standard 4-week interval: 6.3% at 1 week postinjection, 22.9% at 2 weeks postinjection, and 35.4% at 3 weeks postinjection. Only 35.4% of patients had maximal CRT reduction at 4 weeks. Twenty percent of treatment-naive and 34.8% of non-naive patients had a week-4 CRT that was >35 ?m thicker than the earlier occuring lowest CRT value (nadir). The time to maximal CRT reduction was not related to axial length, age, lens status, or history of injections.

Conclusions: Optimal dosing interval for maximal CRT reduction may be less than 4 weeks for a significant proportion of patients. Most patients will be classified as complete responders if intervals less than 4 weeks are used to assess anti-VEGF treatment response. Disease load rather than eye size appears to be the driver of anti-VEGF treatment duration and therefore, dosing interval needs to be optimized in the cohort of short-term responders.

SUBMITTER: Bontzos G

PROVIDER: S-EPMC7416963 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Nonresponders to Ranibizumab Anti-VEGF Treatment Are Actually Short-term Responders: A Prospective Spectral-Domain OCT Study.

Bontzos Georgios G Bagheri Saghar S Ioanidi Larissa L Kim Ivana I Datseris Ioannis I Gragoudas Evangelos E Kabanarou Stamatina S Miller Joan J Tsilimbaris Miltiadis M Vavvas Demetrios G DG

Ophthalmology. Retina 20191111 12

<h4>Purpose</h4>To investigate the inter-individual variability in duration of anti-vascular endothelial growth factor (VEGF) treatment effect in neovascular age-related macular degeneration (nvAMD).<h4>Design</h4>Prospective observational multi-centered study.<h4>Participants</h4>Forty-eight patients with nvAMD treated with anti-VEGF injections were included. Both treatment naive (n=25) as well as patients who had previously received treatment with ranibizumab (n=23) more than one month prior t ...[more]

PMID: 31937473

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Project description:PurposeTo evaluate spectral-domain (SD)-OCT features associated with baseline vision and visual outcomes in the prospective, multicenter Study Evaluating Dosing Regimens for Treatment with Intravitreal Ranibizumab Injections in Subjects with Macular Edema following Retinal Vein Occlusion (SHORE).DesignPost hoc analysis of prospective clinical trial data.ParticipantsTwo hundred two participants in the 15-month, phase 4 SHORE study comparing monthly versus pro re nata ranibizumab after 7 monthly doses in eyes with retinal vein occlusion (RVO) with macular edema.MethodsBaseline SD-OCT images were assessed for (1) central subfield thickness (CST); (2) presence of vitreomacular adhesion, vitreomacular traction, or epiretinal membrane; (3) presence, location, and amount of intraretinal fluid or subretinal fluid (SRF); (4) presence, location, and amount of hyperreflective foci (HF); (5) disorganization of retinal inner layers (DRIL); and (6) disruption of external limiting membrane (ELM), ellipsoid zone (EZ), and interdigitation zone (IZ). Univariate and multivariate regression analyses were performed to evaluate the association of these features with baseline best-corrected visual acuity (BCVA) and change in BCVA after 7 monthly ranibizumab injections.Main outcome measuresAssociation of SD-OCT features with baseline BCVA and change in BCVA after 7 monthly ranibizumab injections.ResultsBefore therapy, worse baseline BCVA was associated with ERM presence (P = 0.0045), thicker SRF (P = 0.0006), larger intraretinal cysts (P = 0.0015), and higher percentage of DRIL (P < 0.0001), percentage of ELM disruption (P < 0.0001), percentage of EZ disruption (P = 0.0003), and percentage of IZ disruption (P = 0.0018). In multivariate models, only percentage of ELM disruption independently impacted baseline BCVA (P < 0.0001). After 7 monthly ranibizumab injections, mean BCVA improved by 18.3±12.6 Early Treatment Diabetic Retinopathy Study letters in treated eyes. The only factors independently associated with BCVA gain after 7 monthly ranibizumab treatments were younger age (P < 0.0001) and worse baseline BCVA (P < 0.0001).ConclusionsAlthough SD-OCT features may be associated with presenting vision in eyes with macular edema and RVO, most eyes treated with ranibizumab achieve substantial vision gains, and only older age and better baseline BCVA limited visual improvements.

Project description:PURPOSE:To determine optimal objective, machine-derived variables and variable combinations from Scheimpflug and spectral-domain (SD) OCT imaging to distinguish the clinically unaffected eye in patients with asymmetric keratoconus (AKC) from a normal control population. DESIGN:Retrospective case-control study. PARTICIPANTS:Thirty clinically unaffected eyes with no physical findings on slit-lamp examination, no definitive abnormalities on corneal imaging, and corrected distance acuity of 20/20 or better from 30 patients with highly AKC eyes and 60 eyes from 60 normal control patients who had undergone uneventful LASIK with at least 2 years of stable follow-up (controls). METHODS:Scheimpflug and SD OCT imaging were obtained in all eyes, and receiver operating characteristic (ROC) curves were generated to determine area under the curve (AUC), sensitivity, and specificity for each machine-derived variable and variable combination. MAIN OUTCOME MEASURES:Distinguishing AKC eyes from controls as determined by AUC, sensitivity, and specificity. RESULTS:No individual machine-derived metric from Scheimpflug or SD OCT technology yielded an AUC higher than 0.75. Combining 5 Scheimpflug metrics (index height decentration [IHD], index vertical asymmetry [IVA], pachymetry apex, inferior-superior value, and Ambrosio's Relational Thickness Maximum [ARTmax]) yielded the best Scheimpflug results (AUC 0.86, sensitivity 83%, specificity 83%). Combining 11 SD OCT thickness metrics (minimum-median, temporal outer, superior nasal outer, minimum, epithelium minimum-maximum, epithelial standard deviation, superior inner, superior outer, superior temporal outer, superior nasal inner, central) yielded the best SD OCT results (AUC 0.96, sensitivity 89%, specificity 89%). Combining 13 total Scheimpflug/SD OCT metrics yielded the best results overall (AUC 1.0, sensitivity 100%, specificity 100%). The most impactful variables in combined models included epithelial thickness variability and total focal corneal thickness variability from SD OCT and anterior curvature and topometric indices from Scheimpflug technology. No posterior corneal metrics were impactful in modeling. CONCLUSIONS:Individual machine-derived metrics from Scheimpflug and SD OCT imaging poorly distinguished normal eyes from minimally affected eyes from patients with highly AKC. Combined SD OCT metrics performed better than combined Scheimpflug metrics. Combining anterior curvature and asymmetry indices from Scheimpflug with regional total thickness and epithelial thickness variability metrics from SD OCT clearly distinguished the 2 populations. Posterior corneal indices were not useful in distinguishing populations.

Project description:PURPOSE:To compare the diagnostic ability of wide-field swept-source optical coherence tomography (SS-OCT) retinal nerve fiber layer (RNFL) maps with spectral-domain OCT (SD-OCT) maps for detection of preperimetric (PPG) and early glaucoma (EG). PATIENTS AND METHODS:One hundred and forty-six eyes, including 37 healthy eyes, 38 eyes with PPG, and 71 eyes with EG, were analyzed. The patients underwent both SD-OCT (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA, USA) and wide-field SS-OCT scanning (DRI-OCT-1 Atlantis; Topcon, Tokyo, Japan). By SD-OCT, circumpapillary RNFL and macular ganglion cell analyses were performed. SS-OCT provides a wide-field RNFL thickness map and a SuperPixel map, which are composed of an RNFL deviation map of the peripapillary area and a deviation map of the composition of the ganglion cell layer with the inner plexiform layer and RNFL [GC-IPL+RNFL] in the macular area. The ability to discriminate PPG and EG from healthy eyes was assessed according to sensitivity, specificity and area under the receiver operating characteristic curve for parameters and criteria provided by SD-OCT and wide-field SS-OCT scanning. RESULTS:The wide-field RNFL thickness map obtained by SS-OCT showed the highest sensitivity to PPG and EG (92.1 and 97.2%, respectively) as compared with the other, SD-OCT criteria. The wide-field RNFL thickness map showed PPG-diagnostic performance comparable to the SD-OCT RNFL thickness and GC-IPL deviation maps (p?=?0.453 and 0.180), and PPG-diagnostic performance superior to the SD-OCT RNFL deviation and GC-IPL thickness maps (p?=?0.003 and 0.039). In EG, the wide-field RNFL thickness and SuperPixel maps showed diagnostic performance comparable to the SD-OCT thickness and deviation maps (p?=?0.065 to 0.100), except for the GC-IPL thickness map (p?=?0.004). CONCLUSIONS:The wide-field SS-OCT RNFL thickness maps showed a diagnostic ability for distinguishing PPG and EG from healthy eyes that was similar to that of SD-OCT. In the clinical setting, these maps can be effective for detection of early-glaucomatous changes.

Project description:BackgroundTo compare the cost-effectiveness of treating early responders versus early nonresponders to an atypical antipsychotic (risperidone) and the cost-effectiveness of treating early nonresponders maintained on risperidone versus those switched to olanzapine.MethodsThis post hoc analysis used data from a randomized, double-blind, 12-week schizophrenia study (Study Code: HGMN, n = 628). Participants were initially assigned to risperidone therapy. Early response was defined as a ≥ 20% improvement on the Positive and Negative Syndrome Scale (PANSS) total score from baseline to two weeks. Early responders continued on risperidone, whereas early nonresponders were randomized in a double-blind manner to continue on risperidone or switch to olanzapine for 10 additional weeks. Early responders and early nonresponders maintained on risperidone were compared for health-state utilities (benefits) and total cost over the 12-week study; early nonresponders maintained on risperidone or switched to olanzapine were compared from randomization (10-week period). Utilities were derived from the PANSS and adverse events. Mixed models were used to assess group differences in utilities. Treatment costs were calculated based on health states. Incremental cost-effectiveness ratios were then utilized to compare treatment groups.ResultsEarly responders to risperidone had significantly greater total utility and lower total treatment costs than early nonresponders to risperidone. Compared with early nonresponders who continued on risperidone, those who were switched to olanzapine had significantly higher total utility scores at endpoint and numerically lower total treatment costs, reflecting significantly lower nonmedication treatment costs, even though medication costs were significantly higher compared with generic risperidone.ConclusionTreatment of early responders was more cost-effective than treatment of early nonresponders to atypical antipsychotic therapy. Switching early nonresponders to olanzapine resulted in improved treatment effectiveness, met the criteria for some dominance, and appeared modestly more cost-effective than maintaining treatment with generic risperidone.

Dataset Information

Nonresponders to Ranibizumab Anti-VEGF Treatment Are Actually Short-term Responders: A Prospective Spectral-Domain OCT Study.

Publications

Nonresponders to Ranibizumab Anti-VEGF Treatment Are Actually Short-term Responders: A Prospective Spectral-Domain OCT Study.

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