Author: Alexander Schuster
Co-authors: Christian Wolfram, Tobias Hudde, Alexander Klatt, Birthe Schnegelsberg, Heven Midani-Oezkan, Focke Ziemssen, Norbert Pfeiffer
Abstract
Purpose:Regular optical coherence tomography (OCT)-examinations are indispensable for monitoring the disease status and treatment success in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). The ALBATROS data collection surveyed the influence of sequential OCTs as recommended by three German Ophthalmology Societies, namely the German Ophthalmological Society (DOG), the German Retina Society, and the Professional Association of Ophthalmologists in Germany on patient quality of life (QoL) and furthermore provides information about the mean time between OCT-visit intervals which can be used to align guideline recommendations with real-world evidence.
Setting/Venue:
ALBATROS was a multi-center data collection addressing patients diagnosed with nAMD, DME or retinal vein occlusion (RVO) to assess patients’ care situation over twelve months between January 2016 and September 2019. It included a baseline visit and a visit twelve months later when data were collected.
Methods:
ALBATROS captured information about best corrected visual acuity (BCVA), central retinal thickness (CRT) measured by OCT, QoL assessed at baseline and month 12 using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), and the number of anti-VEGF treatments. This analysis focused on the impact of the frequency of OCT examinations and injections on BCVA and NEI-VFQ-25 scores in nAMD and DME-patients. Data were analyzed as observed. Baseline data were assessed with the full analysis set (FAS); average and maximum time intervals between OCT visits and changes from baseline in NEI-VFQ-25 scores were analyzed with the completed analysis set (CAS) which includes only patients completing the month 12 visit. NEI-VFQ-25 was calculated in overall, composite and Rasch-transformed scales. BCVA and QoL were analyzed for each indication cohort and in addition for subgroups of cohorts, stratified by OCT-categories (≤3 OCTs, >3 to <9 OCTs and ≥9 OCTs). Average and maximum time intervals between OCT-examinations were analyzed by descriptive statistics.
Results:
Data for 1444 nAMD- and 45 DME-patients were collected by 102 German sites. Across all indications and treatment regimens, the mean interval between two OCT-visits was 57 days with a mean maximum duration of 104 days, implicating late OCT-examinations for >50% and very late OCT-examinations for >30% of the patients. Mean(±SD) improvement in vision from baseline to last visit was 3.4±19.3 ETDRS-letters for nAMD- and 4.1±13.3 letters for DME-patients. A mean of 7.2 OCTs and 5.2 anti-VEGF injections were performed for nAMD-patients and 7.1 OCTs and 5.0 injections for DME-patients at median observation time for each group of 365 days. No relevant change was seen in Rasch-transformed QoL scales for either group. In general, an increasing number of OCT-examinations was not associated with higher VFQ-25 scores in nAMD-patients but in DME-patients. For instance, ‘general health scale’ decreased by 2.4 points for patients with >3 to ≤6 OCTs (mean of 3.5±1.7 injections) but increased by 2.6 for patients with >6 to ≤9 OCTs (mean of 5.3±2.6 injections) up to 6.5 points for patients receiving >9 OCTs (mean of 8.3±3.2 injections).
Conclusions:
Higher numbers of injections and OCT-examinations were associated with improvements in BCVA and in distinct QoL subscales, especially for patients with DME. In contrast to nAMD-patients, for DME-patients there was a general trend for higher VFQ-25 QoL-subscale scores with an increasing number of OCT-examinations being performed. The results showed extended time intervals of OCT-visits for most of the patients which were substantially longer than the recommended interval of 28 to 35 days and which were irrespective of the treatment regimen. This, along with a lower number of anti-VEGF injections might prevent the full exploitation of the potential of anti-VEGF-therapies.
