TY - JOUR
T1 - Effect of Aflibercept on Diabetic Retinopathy Severity and Visual Function in the RECOVERY Study for Proliferative Diabetic Retinopathy
AU - Alagorie, Ahmed Roshdy
AU - Velaga, Swetha
AU - Nittala, Muneeswar Gupta
AU - Yu, Hannah J.
AU - Wykoff, Charles C.
AU - Sadda, Srinivas R.
N1 - Funding Information:
Disclosure(s): All authors have completed and submitted the ICMJE disclosures form. The author(s) have made the following disclosure(s): C.C.W.: Consultant - Acuela, Aerpio, Alimera Sciences, Allegro, Alnylam, Actic Vision, Bausch & Lomb, Bayer, Concept Therapeutics, DORC, Eyepoint, Gyroscope, IVERIC Bio, Merck, Notal Vision, ONL Therapeutics, Oxurion, Palatin, PolyPhotonix, Takeda, Thea Open Innovation, Adverum, Allergan, Apellis, KHB, Clearside Biomedical, Genentech, Kodiak Sciences, NGM Biopharmaceuticals, Novartis, Opthea, Recens Medical, Regenxbio, Roche, Regeneron; Financial support - Aerie Pharmaceuticals, Aldeyra, Gemini Therapeutics, Graybug Vision, IONIS Pharmaceutical, LMRI, Mylan, Neurotech Pharmaceuticals, Outlook Therapeutics, Samsung Bioepis, Senju, Taiwan Lipsome Company, Zbrane BioPharma, Santen, Adverum, Allergan, Apellis, KHB, Clearside Biomedical, Genentech, Kodiak Sciences, NGM Biopharmaceuticals, Novartis, Opthea, Recens Medical, Regenxbio, Roche; Lecturer - RegeneronS.R.S.: Consultant - Optos, Centervue, Heidelberg, Roche/Genentech, Novartis, Allergan, Amgen, Bayer; Financial support - Carl Zeiss Meditec; Nonfinancial support - Carl Zeiss Meditec, Nidek, Topcon Supported by Regeneron, Tarrytown, New York. The sponsor or funding organization had no role in the design or conduct of this research. Obtained funding: Wykoff
Publisher Copyright:
© 2020 American Academy of Ophthalmology
PY - 2021/5
Y1 - 2021/5
N2 - Purpose: To evaluate the effect of intravitreal aflibercept on diabetic retinopathy (DR) severity and visual function in patients with proliferative DR (PDR) without diabetic macular edema (DME). Design: Prospective, longitudinal, multicenter clinical trial. Participants: Forty eyes of 40 patients with PDR and no DME were enrolled in this study. Patients were randomized into monthly and quarterly 2-mg aflibercept injection cohorts and were treated over a period of 12 months. Methods: All patients underwent ultra-widefield fundus imaging including pseudocolor and fluorescein angiography using an Optos 200Tx device. Main Outcome Measures: Severity of DR at baseline, month 6, and month 12 was evaluated using the DR severity scale (DRSS). The DRSS scores were correlated with the 25-item Visual Function Questionnaire (VFQ-25) and 39-item Visual Function Questionnaire (VFQ-39) scores at baseline and month 12. Results: Mean age of the patients was 48.2 years (range, 25–75 years), mean duration of diabetes mellitus was 16.1 years (range, 2–36 years), and median glycated hemoglobin level was 8.8% (IQR, 7.4%–10%). Both monthly and quarterly groups demonstrated a statistically significant regression in DRSS from baseline to month 12 (P < 0.001). The monthly group demonstrated a statistically significant greater regression of DRSS score at the month 6 visit compared with the quarterly group (P = 0.019). However, the difference between the two groups became statistically insignificant at month 12 visit (P = 0.309). Also no difference was found in mean VFQ-25 and VFQ-39 composite scores between the monthly and quarterly groups at month 12 (P = 0.947 and P = 0.921, respectively). The improvement in mean VFQ-25 and VFQ-39 composite scores at month 12 was correlated significantly with improvement in DRSS score (r = 0.384 and P = 0.039, and r = 0.361 and P = 0.046, respectively). Conclusions: In this study of eyes with PDR without DME, both monthly and quarterly aflibercept injection groups showed significant improvement in DR severity at month 12 compared with baseline. The improvement in DRSS score was associated with an improvement in VFQ-25 and VFQ-39 composite score.
AB - Purpose: To evaluate the effect of intravitreal aflibercept on diabetic retinopathy (DR) severity and visual function in patients with proliferative DR (PDR) without diabetic macular edema (DME). Design: Prospective, longitudinal, multicenter clinical trial. Participants: Forty eyes of 40 patients with PDR and no DME were enrolled in this study. Patients were randomized into monthly and quarterly 2-mg aflibercept injection cohorts and were treated over a period of 12 months. Methods: All patients underwent ultra-widefield fundus imaging including pseudocolor and fluorescein angiography using an Optos 200Tx device. Main Outcome Measures: Severity of DR at baseline, month 6, and month 12 was evaluated using the DR severity scale (DRSS). The DRSS scores were correlated with the 25-item Visual Function Questionnaire (VFQ-25) and 39-item Visual Function Questionnaire (VFQ-39) scores at baseline and month 12. Results: Mean age of the patients was 48.2 years (range, 25–75 years), mean duration of diabetes mellitus was 16.1 years (range, 2–36 years), and median glycated hemoglobin level was 8.8% (IQR, 7.4%–10%). Both monthly and quarterly groups demonstrated a statistically significant regression in DRSS from baseline to month 12 (P < 0.001). The monthly group demonstrated a statistically significant greater regression of DRSS score at the month 6 visit compared with the quarterly group (P = 0.019). However, the difference between the two groups became statistically insignificant at month 12 visit (P = 0.309). Also no difference was found in mean VFQ-25 and VFQ-39 composite scores between the monthly and quarterly groups at month 12 (P = 0.947 and P = 0.921, respectively). The improvement in mean VFQ-25 and VFQ-39 composite scores at month 12 was correlated significantly with improvement in DRSS score (r = 0.384 and P = 0.039, and r = 0.361 and P = 0.046, respectively). Conclusions: In this study of eyes with PDR without DME, both monthly and quarterly aflibercept injection groups showed significant improvement in DR severity at month 12 compared with baseline. The improvement in DRSS score was associated with an improvement in VFQ-25 and VFQ-39 composite score.
KW - Aflibercept
KW - Diabetic retinopathy severity
KW - Proliferative diabetic retinopathy
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U2 - 10.1016/j.oret.2020.08.018
DO - 10.1016/j.oret.2020.08.018
M3 - Article
C2 - 32882447
AN - SCOPUS:85094939367
VL - 5
SP - 409
EP - 419
JO - Ophthalmology Retina
JF - Ophthalmology Retina
SN - 2468-6530
IS - 5
ER -