{"id":"203dc9924b32","type":"article","url":"https://hartvaat.nl/2024/03/23/photon-aflibercept-8-mg-bij-diabetisch-macula-oedeem-verlengd-doseerinterval/","title":"PHOTON: aflibercept 8 mg bij diabetisch macula-oedeem — verlengd doseerinterval","title_en":"Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial.","category":"preventie","category_label":"Preventie","professions":["internist"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(23)02577-1","source_url":"https://doi.org/10.1016/S0140-6736(23)02577-1","authors":["David M Brown","David S Boyer","Diana V Do","Charles C Wykoff","Taiji Sakamoto","Peter Win","Sunir Joshi","Hani Salehi-Had","András Seres","Alyson J Berliner","Sergio Leal","Robert Vitti","Karen W Chu","Kimberly Reed","Rohini Rao","Yenchieh Cheng","Wei Sun","Delia Voronca","Rafia Bhore","Ursula Schmidt-Ott","Thomas Schmelter","Andrea Schulze","Xin Zhang","Boaz Hirshberg","George D Yancopoulos","Sobha Sivaprasad"],"significance":6,"published":"2024-03-23","source_date":"2024-03-23","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"The PHOTON trial showed that high-dose aflibercept 8 mg with extended dosing intervals up to 16 weeks is noninferior to standard aflibercept for diabetic macular edema, reducing treatment burden for this chronic eye condition.","created":"2026-07-03T10:30:49Z","updated":"2026-07-03T13:29:52Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De PHOTON-trial toonde dat aflibercept 8 mg met verlengd doseerinterval (tot 16 weken) non-inferieur was aan standaard aflibercept 2 mg bij diabetisch macula-oedeem. Minder injecties verbeteren de behandellast voor patiënten.","abstract_original":"BACKGROUND: A high-dose formulation of intravitreal aflibercept (8 mg) could improve treatment outcomes in diabetic macular oedema (DMO) by requiring fewer injections than the standard comparator, aflibercept 2 mg. We report efficacy and safety results of aflibercept 8 mg versus 2 mg in patients with DMO. METHODS: PHOTON was a randomised, double-masked, non-inferiority, phase 2/3 trial performed at 138 hospitals and specialty retina clinics in seven countries. Eligible patients were adults aged 18 years or older with type 1 or 2 diabetes and centre-involved DMO. Patients were randomly assigned (1:2:1) to intravitreal aflibercept 2 mg every 8 weeks (2q8), aflibercept 8 mg every 12 weeks (8q12), or aflibercept 8 mg every 16 weeks (8q16), following initial monthly dosing. From week 16, dosing intervals for the aflibercept 8 mg groups were shortened if patients met prespecified dose regimen modification criteria denoting disease activity. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at week 48 (non-inferiority margin of 4 letters). Efficacy and safety analyses included all randomly assigned patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov (NCT04429503). FINDINGS: Between June 29, 2020, and June 28, 2021, 970 patients were screened for eligibility. After exclusions, 660 patients were enrolled and randomly assigned to receive aflibercept 8q12 (n=329), 8q16 (n=164), or 2q8 (n=167); two patients were randomly assigned in error and did not receive treatment. 658 (99·7%) patients were treated and included in the full analysis set and safety analysis set (8q12 n=328, 8q16 n=163, and 2q8 n=167). Mean patient age was 62·3 years (SD 10·4). 401 (61%) patients were male. 471 (72%) patients were White. Aflibercept 8q12 and 8q16 demonstrated non-inferior BCVA gains to aflibercept 2q8 (BCVA mean change from baseline 8·8 letters [SD 9·0] in the 8q12 group, 7·9 letters [8·4] in the 8q16 group, and 9·2 letters [9·0] in the 2q8 group). The difference in least squares means was -0·57 letters (95% CI -2·26 to 1·13, p value for non-inferiority <0·0001) between 8q12 and 2q8 and -1·44 letters (-3·27 to 0·39, p value for non-inferiority 0·0031) between aflibercept 8q16 and 2q8. Proportions of patients with ocular adverse events in the study eye were similar across groups (8q12 n=104 [32%], 8q16 n=48 [29%], and 2q8 n=46 [28%]). INTERPRETATION: Aflibercept 8 mg demonstrated efficacy and safety with extended dosing intervals and could decrease treatment burden in patients with DMO. FUNDING: Regeneron Pharmaceuticals and Bayer."}