Outcome Measures to Assess Efficacy of Treatments for Age-Related Macular Degeneration

AbstractTo investigate sensitive outcome measures based exclusively on abnormal points in microperimetry testing of eyes with intermediate age-related macular degeneration (iAMD). 25 eyes of 25 subjects with iAMD had undergone 2 successive tests of mesopic microperimetry with the Macular Integrity Assessment Microperimeter (MAIA), using a custom grid of 33 points spanning the central 14 degrees of the macula. Each point was defined as abnormal if its threshold sensitivity was lower than 1.65 standard deviations (SD) (5%) or 2 SD (2.5%) than the expected threshold in healthy eyes according to the MAIA internal database. Among the 25 eyes there were 11.8 ± 9 and 8.4 ± 8.2 abnormal points at < 5% and < 2.5%, with mean deviation of thresholds from normal − 4.9 ± 1.2 dB and − 5.8 ± 1.5 dB, respectively. These deviations were greater, and their SD smaller, compared with the complete microperimetry grid, − 2.3 ± 2.0 dB. The 95% limits of agreement for average threshold between the 2 successive tests were smaller when only abnormal points were included. Analyzing only abnormal grid points yields an outcome parameter with a greater deviation from normal, a more homogenous dataset, and better test–retest variability, compared with analysis of all grid points. This parameter may thus be more sensitive to change, while moderately limiting the number of potential recruits. The proposed outcome measures should be further investigated as potential endpoints in clinical trials in iAMD.

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Bevacizumab versus Ranibizumab on As-Needed Treatment Regimen for Neovascular Age-Related Macular Degeneration in Turkish Patients

ISRN Ophthalmology ◽

10.1155/2013/151027 ◽

2013 ◽

Vol 2013 ◽

pp. 1-6 ◽

Cited By ~ 1

Author(s):

Abdullah Ozkaya ◽

Zeynep Alkin ◽

Yalcin Karakucuk ◽

Dilek Yasa ◽

Ahmet Taylan Yazici ◽

...

Keyword(s):

Macular Degeneration ◽

Treatment Regimen ◽

Outcome Measures ◽

Intravitreal Bevacizumab ◽

Age Related Macular Degeneration ◽

Secondary Outcome ◽

Age Related ◽

Significant Difference ◽

Retrospective Comparative Study ◽

Number Of Injections

Purpose. To compare the efficacy of intravitreal bevacizumab versus ranibizumab in the treatment of neovascular age-related macular degeneration (nAMD). Methods. Retrospective, comparative study. The newly diagnosed nAMD patients who were treated with intravitreal bevacizumab or ranibizumab on an as-needed treatment regimen were included in the study. Main outcome measures were the change in best corrected visual acuity (BCVA), and central retinal thickness (CRT). Secondary outcome measures were the number of injections, and complications. Results. A total of 154 patients were included in the study. Bevacizumab group consisted of 79 patients, and ranibizumab group consisted of 74 patients. Mean follow-up time was 18.9 months, and 18.3 months in the bevacizumab and ranibizumab groups, respectively. There was not a significant difference between the two groups regarding the change in BCVA and CRT at all time points (P>0.05 for all). The mean number of injections at month 12 was 4.8 and 4.7 in bevacizumab and ranibizumab groups, respectively (P>0.05). No serious complications were detected in any of the groups. Conclusion. Both of the bevacizumab and ranibizumab found to be effective in the treatment of nAMD in regards of functional and anatomical outcomes with similar number of treatments and similar side effects.

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Patient-reported outcome measures in the management of neovascular age-related macular degeneration: a 1-year prospective study

BMJ Open Ophthalmology ◽

10.1136/bmjophth-2019-000353 ◽

2019 ◽

Vol 4 (1) ◽

pp. e000353 ◽

Cited By ~ 1

Author(s):

Elma Jelin ◽

Torbjørn Wisløff ◽

Øystein Kalsnes Jørstad ◽

Turid Heiberg ◽

Morten Carstens Moe

Keyword(s):

Macular Degeneration ◽

Outcome Measures ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Age Related Macular Degeneration ◽

Euroqol Group ◽

Age Related ◽

Patient Reported ◽

Symptom Status ◽

Endothelial Growth Factor

ObjectiveTo prospectively explore the following patient-reported outcome measures (PROMs) in the management of neovascular age-related macular degeneration (nAMD): (1) self-reported visual function, (2) symptom-state, (3) general-health and (4) satisfaction of treatment.Methods and analysisCorresponding to the four PROMs, participants responded to the following questionnaires: (1) National Eye Institute Visual-Functioning-Questionnaire (NEI-VFQ-25), (2) Patient-Acceptable-Symptom-Status (PASS 5), (3) EuroQol-Group-Questionnaire (EQ-5D-3L) and (4) Dimensions of Importance in Treatment of nAMD (DITAMD). Data were collected at baseline and after 3, 6 and 12 months of intravitreal antivascular endothelial growth factor treatment. Results were evaluated with t-tests and mixed linear regression analyses.ResultsThe study included 197 patients. At baseline NEI-VFQ-25 (79.53±14.52) and EQ-5D (0.74±0.28) had relatively high scores, whereas PASS 5 was below ‘acceptable’ (3.30±0.80). At 12 months NEI-VFQ-25 and PASS 5 showed significant improvement, whereas EQ-5D and DITAMD remained unchanged. At baseline patients receiving treatment of the better-seeing eye (BSE) (n=52) reported significantly worse NEI-VFQ-25 and PASS 5 than patients for whom treatment only involved the worse-seeing eye (WSE), (n=145). In contrast to BSE patients, there was no improvement of NEI-VFQ-25 for WSE patients at 12 months, despite a significant improvement in best-corrected visual acuity (BCVA). Two independent variables, treatment including the BSE and BCVA for the treated eye, were found to predict both NEI-VFQ-25 and PASS 5.ConclusionAfter 12 months of nAMD treatment, there was a significant improvement in PASS 5 and NEI-VFQ-25, the latter depending on whether therapy included BSE. EQ-5D and DITAMD remained unaltered.

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AI-based structure-function correlation in age-related macular degeneration

Eye ◽

10.1038/s41433-021-01503-3 ◽

2021 ◽

Author(s):

Leon von der Emde ◽

Maximilian Pfau ◽

Frank G. Holz ◽

Monika Fleckenstein ◽

Karsten Kortuem ◽

...

Keyword(s):

Artificial Intelligence ◽

Clinical Trials ◽

Visual Acuity ◽

Structure Function ◽

Macular Degeneration ◽

Outcome Measures ◽

Multimodal Imaging ◽

Age Related Macular Degeneration ◽

Age Related ◽

Function Correlation

AbstractSensitive and robust outcome measures of retinal function are pivotal for clinical trials in age-related macular degeneration (AMD). A recent development is the implementation of artificial intelligence (AI) to infer results of psychophysical examinations based on findings derived from multimodal imaging. We conducted a review of the current literature referenced in PubMed and Web of Science among others with the keywords ‘artificial intelligence’ and ‘machine learning’ in combination with ‘perimetry’, ‘best-corrected visual acuity (BCVA)’, ‘retinal function’ and ‘age-related macular degeneration’. So far AI-based structure-function correlations have been applied to infer conventional visual field, fundus-controlled perimetry, and electroretinography data, as well as BCVA, and patient-reported outcome measures (PROM). In neovascular AMD, inference of BCVA (hereafter termed inferred BCVA) can estimate BCVA results with a root mean squared error of ~7–11 letters, which is comparable to the accuracy of actual visual acuity assessment. Further, AI-based structure-function correlation can successfully infer fundus-controlled perimetry (FCP) results both for mesopic as well as dark-adapted (DA) cyan and red testing (hereafter termed inferred sensitivity). Accuracy of inferred sensitivity can be augmented by adding short FCP examinations and reach mean absolute errors (MAE) of ~3–5 dB for mesopic, DA cyan and DA red testing. Inferred BCVA, and inferred retinal sensitivity, based on multimodal imaging, may be considered as a quasi-functional surrogate endpoint for future interventional clinical trials in the future.

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Age related macular degeneration (ARMD) – pathophysiological and clinical features and therapeutic concepts

Therapeutische Umschau ◽

10.1024/0040-5930.58.1.28 ◽

2001 ◽

Vol 58 (1) ◽

pp. 28-35 ◽

Cited By ~ 1

Author(s):

Ursula Körner-Stiefbold

Keyword(s):

Macular Degeneration ◽

Clinical Features ◽

Altersbedingte Makuladegeneration ◽

Age Related Macular Degeneration ◽

Genetische Faktoren ◽

Age Related ◽

Therapeutic Concepts

Die altersbedingte Makuladegeneration (AMD) ist eine der häufigsten Ursachen für einen irreversiblen Visusverlust bei Patienten über 65 Jahre. Nahezu 30% der über 75-Jährigen sind von einer AMD betroffen. Trotz neuer Erkenntnisse in der Grundlagenforschung ist die Ätiologie, zu der auch genetische Faktoren gehören, noch nicht völlig geklärt. Aus diesem Grund sind die Behandlungsmöglichkeiten zum jetzigen Zeitpunkt noch limitiert, so dass man lediglich von Therapieansätzen sprechen kann. Die derzeit zur Verfügung stehenden Möglichkeiten wie medikamentöse, chirurgische und laser- und strahlentherapeutische Maßnahmen werden beschrieben.

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