Author: Tariq Aslam (United Kingdom)
Co-authors: Jane Barratt, Vincent Daien, Bora Eldem, Robert P. Finger, Richard P. Gale, Laurent Kodjikian
Purpose
Clinical studies routinely report the effect of treatment with anti-vascular endothelial growth factor (anti-VEGF) agents on functional and anatomic outcomes in patients with neovascular age-related macular degeneration (nAMD); however, few studies assess the impact of the management of nAMD from the perspective of the patient (or caregiver). The heterogeneity of patient characteristics, and multiple factors impacting patient psychology, should be considered when evaluating patient-reported outcomes in randomized controlled trials (RCTs). Non-interventional observational studies may provide a setting closer to real-world practices to evaluate these perspectives. The aim of this systematic literature review was to describe patient experiences of the management of nAMD in routine clinical practice in terms of quality of life (QoL), psychosocial and psychological impact of disease, and treatment burden.
Setting/Venue
Patients with nAMD managed with anti-VEGF therapy in non-RCT settings.
Methods
Electronic searches were conducted in EMBASE and MEDLINE for articles published up to October 2020 according to pre-defined search criteria. Abstracts from key conferences (including EURETINA and ARVO annual meetings) held in the last two years were also searched. Identified articles were manually screened based on the title and abstract, and potentially relevant full-text articles were assessed for eligibility. Articles on real-world clinical practice were eligible if they described the impact of anti-VEGF therapy on QoL of patients/caregivers with nAMD, psychosocial and psychological impact, and qualitative outcomes in observational and non-interventional studies. Findings are reported according to PRISMA guidelines. Of 856 records identified, 63 met the inclusion criteria (57% of studies were single-center [only three reports included centers from more than one country], and 56% of studies were cross-sectional [providing single point-in-time assessments]).
Results
QoL was evaluated in 24/63 (38%) studies using various assessment tools; in five studies evaluating the effect of anti-VEGF treatment using the 25-item National Eye Institute Visual Function Questionnaire (NEI-VQF-25), QoL improved early (by month 1), with improvements sustained at 1 year in most studies. In addition to visual acuity, age, social support, and marital status appeared to impact QoL; one study (n=142) found depression correlated significantly with NEI VFQ-25, but another (n=51) concluded depression was unrelated to QoL. Prevalence of depression or depressive symptoms in patients treated with anti-VEGFs varied widely (8–42%), but in the absence of longitudinal evidence, a causal relationship cannot be concluded. Only one study evaluated the effect of anti-VEGFs on anxiety and depression, showing treat-and-extend therapy reduces mental burden over 1 (n=40) and 2 (n=25) years. In four studies reporting perspectives of treat-and-extend vs pro re nata dosing, treat-and-extend regimens were associated with reduced patient/caregiver burden. One study highlighted treat-and-extend regimens may allow patients to better prepare mentally for injection appointments. Six studies reported perspectives related to caregiver burden, and despite >60% of patients requiring someone to accompany them to clinic appointments, approximately 75% of caregivers did not necessarily consider this burdensome.
Conlusions
In observational studies evaluating the effects of anti-VEGF treatment, patient QoL improved early (by month 1), with some improvements sustained at 1 year. The heterogeneity of how QoL and other patient-relevant concepts, such as mental health, were evaluated highlights the need for a standardized approach if results from individual studies in patients with nAMD are to be more easily compared. It remains to be established whether sustained improvement in QoL should be a realistic expectation of anti-VEGF treatment (particularly in longer-term treatment). In nAMD, depression and anxiety have complex and nuanced origins rather than being simply related to anti-VEGF injections or poor vision alone. A coordinated, holistic approach to patient care and patient-physician dialogue are therefore key to optimizing the likelihood of patient well-being, as well as visual outcome. As long as anti-VEGF treatment maintains vision, studies indicate that patients prefer a treat-and-extend regimen due to reduced burden and certainty of injection schedule. Overall, few studies evaluate the management of nAMD from a patient’s perspective and none directly compare the perspectives of the patient with those of their physician. This group has initiated a multinational qualitative study and quantitative survey to investigate these topics.
Financial Disclosure
Tariq Aslam: Consultant: Novartis, Bayer, Laboratoires, Théa Pharmaceuticals, Bausch & Lomb, Oraya. Jane Barratt: Nothing to disclose. Vincent Daien: Consultant: Bayer, Novartis, Théa, Horus Pharma. Bora Eldem: Consultant: Bayer, Novartis, Allergan. Robert P. Finger: Grant: Novartis, CentreVue, Heidelberg Engineering, Zeiss; Consultant: Novartis, Bayer, Roche/Genentech, Ellex, Alimera, Allergan, Santhera, Inositec, Opthea; Support for travel: Novartis. Richard P. Gale: Consultant/advisory boards: Novartis, Bayer, Allergan, Alimera, Santen; Educational travel grants: Novartis, Bayer, Allergan, Heidelberg; Research grants: Allergan, Bayer, Novartis, Roche. Laurent Kodjikian: Consultant: Abbvie, Alcon, Allergan, Bayer, Krystal Biotech, Novartis, Regeneron, Théa. Anat Loewenstein: Consultant: Allergan, Bayer, Beyeonics, Forsight Labs, Notal Vision, Novartis, Roche. Mali Okada: Travel support: Bayer; Honorarium for lectures: Bayer, Allergan. Francisco J. Rodríguez: Consultant: Bayer, Novartis, Roche; Speaker: Bayer, Novartis, Roche; Research funds: Novartis. Tien Yin Wong: Clinical trial grants: Allergan, Bayer, Boehringer-Ingelheim, Genentech, Merck, Novartis, Oxurion (formerly ThromboGenics), Roche, Samsung Bioepis, NMRC Singapore, Novartis Singapore; Consulting fees/travel support/review fees/consultant fees: Allergan, Bayer, Boehringer-Ingelheim, Genentech, Merck, Novartis, Oxurion (formerly ThromboGenics), Roche, Samsung Bioepis; Stock: Plano, EyRIS. Medical writing support was provided by ApotheCom, and funded by Bayer Consumer Care AG, Pharmaceuticals, Switzerland.
Comments
Important add below co-authors: 7. - Anat Loewenstein: Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel 8. - Mali Okada: Royal Victorian Eye and Ear Hospital, Melbourne, VIC, Australia 9. - Francisco J. Rodríguez: Department of Ophthalmology, Fundación Oftalmológica Nacional and Universidad del Rosario School of Medicine, Bogotá, Colombia 10. - Tien Yin Wong: Singapore Eye Research Institute, Singapore National Eye Centre, Singapore; Ophthalmology and Visual Sciences Academic Clinical Program, Duke-NUS Medical School, Singapore
