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Testing the clinical value of multifocal electroretinography and microperimetry and the effects of intravitreal therapy with ranibizumab on macular function in the course of wet age-related macular degeneration: a 1-year prospective study.

ABSTRACT: PURPOSE:To investigate the clinical value of multifocal electroretinography (mfERG) and microperimetry and the effects of intravitreal therapy with ranibizumab (Lucentis®) on macular function in the course of neovascular age-related macular degeneration (nAMD). MATERIALS AND METHODS:We conducted a prospective single-arm interventional cohort study with 20 nAMD patients older than 50 years. Examinations were scheduled monthly for 1 year during intravitreal therapy with ranibizumab. The examinations included mfERG, microperimetry, spectral domain optical coherence tomography, and best-corrected visual acuity using ETDRS score. RESULTS:During the 12-month observation period, a significant positive linear correlation between the logarithm of minimum angle of resolution (logMAR) and scotoma area (r=0.28, 95% confidence interval [CI] 0.21-0.35), between logMAR and fovea thickness in optical coherence tomography (r=0.11, 95% CI 0.04-0.2), and a significant negative correlation between logMAR and mfERG (-0.37, 95% CI -0.43 to -0.31) were observed. A significant ranibizumab effect on logMAR was found (P=0.0065). From a total of 25 relapses, 14 were able to be predicted correctly by mfERG P1 decrease in the preceding month. However, there was no statistically significant relation between prediction and observed relapses (Fisher's exact test, P=0.6726). CONCLUSION:Our results indicate a possible role of mfERG and microperimetry in the monitoring of macular function and prediction of recurrence during intravitreal pharmacotherapy in wet AMD.

SUBMITTER: Reinsberg M

PROVIDER: S-EPMC5388268 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Testing the clinical value of multifocal electroretinography and microperimetry and the effects of intravitreal therapy with ranibizumab on macular function in the course of wet age-related macular degeneration: a 1-year prospective study.

Reinsberg Mihaela M Hilgers Ralf-Dieter RD Lüdeke Inger I Nassar Khaled K Grisanti Swaantje S Grisanti Salvatore S Lüke Julia J Lüke Matthias M

Clinical ophthalmology (Auckland, N.Z.) 20170406

<h4>Purpose</h4>To investigate the clinical value of multifocal electroretinography (mfERG) and microperimetry and the effects of intravitreal therapy with ranibizumab (Lucentis<sup>®</sup>) on macular function in the course of neovascular age-related macular degeneration (nAMD).<h4>Materials and methods</h4>We conducted a prospective single-arm interventional cohort study with 20 nAMD patients older than 50 years. Examinations were scheduled monthly for 1 year during intravitreal therapy with r ...[more]

PMID: 28435212

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Project description:BackgroundAnti-vascular endothelial growth factor (anti-VEGF) agents have become the standard of care in neovascular age-related macular degeneration (nAMD). Despite generally excellent response rates to anti-VEGF therapy, some patients do not respond or may respond suboptimally. In the case of refractory or rapidly recurring fluid in nAMD, clinicians may switch to another anti-VEGF agent. TITAN was an observational study that assessed the effectiveness and safety of intravitreal aflibercept (IVT-AFL) in patients with nAMD refractory to ranibizumab who switched to IVT-AFL after less than 12?months of ranibizumab treatment in routine clinical practice in France.MethodsTITAN was an observational, retrospective and prospective 12-month study conducted at 28 centres in France. Patients with nAMD refractory to ranibizumab were enrolled. Patients who were switched from ranibizumab to IVT-AFL were followed for 12?months. Data were obtained from medical records for retrospectively included patients, and at routine follow-up visits for those included prospectively. The main outcome measure was percentage of patients who achieved treatment success (gain of ?1 Early Treatment Diabetic Retinopathy Study letters in best-corrected visual acuity [BCVA] and/or any reduction in central retinal thickness [CRT]) from baseline to 12?months after switching. A sample size of 225 patients was determined based on a 2-sided 95% confidence interval with a width equal to 0.12 when the sample proportion was 0.70.ResultsWe analysed safety data (N =?217) and clinical outcomes from patients in the per-protocol population (n =?125). The mean (standard deviation) number of IVT-AFL injections was 7.5 (2.6). Treatment success was achieved in 68.8% of patients. Mean BCVA change from baseline to Month 12 was +?1.5 letters (P =?0.105) and the mean CRT change was -?45.0??m (P <? 0.001). In a subgroup analysis, in patients who received three initial monthly IVT-AFL injections, mean BCVA gain was 3.3 letters at Month 12 (P =?0.015). Excluding lack of efficacy and inappropriate scheduling of drug administration, the most common adverse event was eye pain (2.3%).ConclusionsSwitching ranibizumab-refractory patients with nAMD to IVT-AFL may improve visual outcomes in some patients, particularly those who receive three initial monthly injections.Trial registrationClinicalTrials.gov , NCT02321241 . First posted: December 22, 2014; Last update posted: July 2, 2018.

Dataset Information

Testing the clinical value of multifocal electroretinography and microperimetry and the effects of intravitreal therapy with ranibizumab on macular function in the course of wet age-related macular degeneration: a 1-year prospective study.

Publications

Testing the clinical value of multifocal electroretinography and microperimetry and the effects of intravitreal therapy with ranibizumab on macular function in the course of wet age-related macular degeneration: a 1-year prospective study.

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