Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F25%3A10501491" target="_blank" >RIV/00179906:_____/25:10501491 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11120/25:43928742 RIV/00064173:_____/25:43928742

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=gBWMoECRs_" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=gBWMoECRs_</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/s40123-025-01197-w" target="_blank" >10.1007/s40123-025-01197-w</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial

Popis výsledku v původním jazyce

INTRODUCTION: A 24-week phase 3 analysis previously demonstrated equivalent efficacy and comparable tolerability between candidate biosimilar CT-P42 and reference aflibercept in participants with diabetic macular edema. Here, we report long-term outcomes through week 52. METHODS: This was a randomized, double-masked, active-controlled, phase 3 international trial, conducted at 83 study centers across Czech Republic, Estonia, Germany, Hungary, India, Latvia, Lithuania, Poland, Republic of Korea, Russia, Slovakia, Spain, and Ukraine. Adults (aged &gt;= 18 years) diagnosed with type 1 or 2 diabetes mellitus, with diabetic macular edema involving the center of the macula, were randomized (1:1) to receive CT-P42 or reference aflibercept (2 mg in 0.05 mL) by intravitreal injection every 4 weeks (five doses), then every 8 weeks (four doses), over a 52-week study period. Study data were collected from July 2021 to April 2023. Efficacy, safety, and immunogenicity of CT-P42 compared with reference aflibercept were evaluated until week 52. RESULTS: Overall, 306 participants (CT-P42, 153; reference aflibercept, 153) completed the study through week 52. The primary efficacy endpoint of mean change from baseline in best corrected visual acuity through week 8 was reported previously. Improvements in best corrected visual acuity were maintained throughout and were similar between CT-P42 and reference aflibercept, with mean (standard deviation) change from baseline at week 52 of 12.1 (8.9) versus 11.1 (9.9) letters, respectively. Changes from baseline in central subfield thickness and other secondary efficacy endpoints as well as safety endpoints, including treatment-emergent adverse events and immunogenicity, were comparable between groups through week 52. CONCLUSIONS: Results through week 52 support the therapeutic equivalence between CT-P42 and reference aflibercept by demonstrating comparable long-term efficacy, safety, and immunogenicity. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04739306.

Název v anglickém jazyce

Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial

Popis výsledku anglicky

INTRODUCTION: A 24-week phase 3 analysis previously demonstrated equivalent efficacy and comparable tolerability between candidate biosimilar CT-P42 and reference aflibercept in participants with diabetic macular edema. Here, we report long-term outcomes through week 52. METHODS: This was a randomized, double-masked, active-controlled, phase 3 international trial, conducted at 83 study centers across Czech Republic, Estonia, Germany, Hungary, India, Latvia, Lithuania, Poland, Republic of Korea, Russia, Slovakia, Spain, and Ukraine. Adults (aged &gt;= 18 years) diagnosed with type 1 or 2 diabetes mellitus, with diabetic macular edema involving the center of the macula, were randomized (1:1) to receive CT-P42 or reference aflibercept (2 mg in 0.05 mL) by intravitreal injection every 4 weeks (five doses), then every 8 weeks (four doses), over a 52-week study period. Study data were collected from July 2021 to April 2023. Efficacy, safety, and immunogenicity of CT-P42 compared with reference aflibercept were evaluated until week 52. RESULTS: Overall, 306 participants (CT-P42, 153; reference aflibercept, 153) completed the study through week 52. The primary efficacy endpoint of mean change from baseline in best corrected visual acuity through week 8 was reported previously. Improvements in best corrected visual acuity were maintained throughout and were similar between CT-P42 and reference aflibercept, with mean (standard deviation) change from baseline at week 52 of 12.1 (8.9) versus 11.1 (9.9) letters, respectively. Changes from baseline in central subfield thickness and other secondary efficacy endpoints as well as safety endpoints, including treatment-emergent adverse events and immunogenicity, were comparable between groups through week 52. CONCLUSIONS: Results through week 52 support the therapeutic equivalence between CT-P42 and reference aflibercept by demonstrating comparable long-term efficacy, safety, and immunogenicity. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04739306.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30207 - Ophthalmology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Ophthalmology and Therapy

ISSN

2193-8245

e-ISSN

2193-6528

Svazek periodika

14

Číslo periodika v rámci svazku

11

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

15

Strana od-do

2769-2783

Kód UT WoS článku

001560302300001

EID výsledku v databázi Scopus

2-s2.0-105014729530