Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-related Macular Degeneration: A Phase 3 Randomized Trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F25%3A43927644" target="_blank" >RIV/00064173:_____/25:43927644 - isvavai.cz</a>

Výsledek na webu

<a href="https://doi.org/10.1016/j.oret.2024.10.001" target="_blank" >https://doi.org/10.1016/j.oret.2024.10.001</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.oret.2024.10.001" target="_blank" >10.1016/j.oret.2024.10.001</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-related Macular Degeneration: A Phase 3 Randomized Trial

Popis výsledku v původním jazyce

OBJECTIVE: This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis(R), in patients with neovascular age-related macular degeneration (nAMD). DESIGN: This was a multi-center, double-blinded, randomized controlled phase 3 trial. SUBJECTS, PARTICIPANTS, AND CONTROLS: Treatment-naïve patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab. METHODS, INTERVENTION, OR TESTING: Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every four weeks for 48 weeks. MAIN OUTCOME MEASURES: The primary endpoint was change in best-corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8 compared to baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49. RESULTS: Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n=308) and the reference ranibizumab group (n=308). The mean improvement of BCVA was +6.3+-9.13 ETDRS letters in the QL1205 group and +7.3+-8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI) [-2.23, 0.13] and 95% CI [-2.46, 0.36] of the difference between the two treatment groups (P=0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups. CONCLUSIONS: QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD.

Název v anglickém jazyce

Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-related Macular Degeneration: A Phase 3 Randomized Trial

Popis výsledku anglicky

OBJECTIVE: This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis(R), in patients with neovascular age-related macular degeneration (nAMD). DESIGN: This was a multi-center, double-blinded, randomized controlled phase 3 trial. SUBJECTS, PARTICIPANTS, AND CONTROLS: Treatment-naïve patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab. METHODS, INTERVENTION, OR TESTING: Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every four weeks for 48 weeks. MAIN OUTCOME MEASURES: The primary endpoint was change in best-corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8 compared to baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49. RESULTS: Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n=308) and the reference ranibizumab group (n=308). The mean improvement of BCVA was +6.3+-9.13 ETDRS letters in the QL1205 group and +7.3+-8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI) [-2.23, 0.13] and 95% CI [-2.46, 0.36] of the difference between the two treatment groups (P=0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups. CONCLUSIONS: QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30207 - Ophthalmology

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2025

Kód důvěrnosti údajů

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

Název periodika

Ophthalmology: Retina

ISSN

2468-6530

e-ISSN

2468-6530

Svazek periodika

9

Číslo periodika v rámci svazku

4

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

343-351

Kód UT WoS článku

001463823000001

EID výsledku v databázi Scopus

2-s2.0-85208349874