Effect of Initial Management With Aflibercept vs Laser Photocoagulation vs Observation on Vision Loss Among Patients With Diabetic Macular Edema Involving the Center of the Macula and Good Visual Acuity

Abstract

; for the DRCR Retina Network IMPORTANCE Intravitreous injections of antivascular endothelial growth factor agents are effective for treating diabetic macular edema (DME) involving the center of the macula (center-involved DME [CI-DME]) with visual acuity impairment (20/32 or worse). The best approach to treating patients with CI-DME and good visual acuity (20/25 or better) is unknown. OBJECTIVE To compare vision loss at 2 years among eyes initially managed with aflibercept, laser photocoagulation, or observation. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted at 91 US and Canadian sites among 702 adults with type 1 or type 2 diabetes. Participants had 1 study eye with CI-DME and visual acuity of 20/25 or better. The first participant was randomized on November 8, 2013, and the final date of follow-up was September 11, 2018. INTERVENTIONS Eyes were randomly assigned to 2.0 mg of intravitreous aflibercept (n = 226) as frequently as every 4 weeks, focal/grid laser photocoagulation (n = 240), or observation (n = 236). Aflibercept was required for eyes in the laser photocoagulation or observation groups that had decreased visual acuity from baseline by at least 10 letters (Ն 2 lines on an eye chart) at any visit or by 5 to 9 letters (1-2 lines) at 2 consecutive visits. MAIN OUTCOMES AND MEASURES The primary outcome was at least a 5-letter visual acuity decrease from baseline at 2 years. Antiplatelet Trialists' Collaboration adverse events (defined as myocardial infarction, stroke, or vascular or unknown death) were reported. RESULTS Among 702 randomized participants (mean age, 59 years; 38% female [n=264]), 625 of 681 (92% excluding deaths) completed the 2-year visit. For eyes with visual acuity that decreased from baseline, aflibercept was initiated in 25% (60/240) and 34% (80/236) in the laser photocoagulation and observation groups, respectively. At 2 years, the percentage of eyes with at least a 5-letter visual acuity decrease was 16% (33/205), 17% (36/212), and 19% (39/208

<p>The Evolving Treatment of Diabetic Retinopathy</p>

“…[93][94][95] Recent data from protocol V of the DRCR Network examining timing of therapy initiation in patients with center-involved DME and good VA demonstrated that focal macular laser fared equally well as anti-VEGF (aflibercept) therapy at 2 years. [96][97][98] In addition, the same protocol validated a "watchful wait" approach to managing patients with mild DME.…”

Stellungnahme der DOG, der RG und des BVA zur Therapie des diabetischen Makulaödems

“…Gruppen(16, 17, 19 %). In den beiden Gruppen ohne initiale Behandlung mit intravitrealen Medikamenten wurde diese erst begonnen, wenn der Visus um mindestens 10 Buchstaben (oder um 5 Buchstaben an 2 aufeinanderfolgenden Visiten) fiel[150]; das war in 25 % der Lasergruppe und 34 % der Patienten unter alleiniger Beobachtung der Fall. Die Daten belegen, dass für den Fall einer guten Sehfunktion trotz eines vorhandenen Ödems mit zentraler Beteiligung nur ein geringes Risiko einer starken Sehverschlechterung über 2 Jahre vorhanden ist.Ein abwartendes Vorgehen mit Verlaufskontrollen ist in diesem Szenario somit eine sinnvolle Option, die geringere Risiken (Endophthalmitis) mit einer guten Stabilität verbindet.…”

Anti-VEGF therapy is not a magic bullet for diabetic retinopathy

“…With the emergence of significant number of recent clinical trials on different indications of anti-vascular endothelial growth factor (anti-VEGF) in diabetic eye disease, it is time to re-think whether anti-VEGF therapy is the be all and end all treatment for complications of diabetic retinopathy (DR) [1][2][3][4][5]. Initial studies of anti-VEGF therapy for visual impairment due to diabetic macular oedema (DMO) highlighted the importance of aggressive therapy or treat to stability [5].…”