Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-related Macular Degeneration: A Phase 3 Randomized Trial
The result's identifiers
Result code in 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>
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language name
Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-related Macular Degeneration: A Phase 3 Randomized Trial
Original language description
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.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30207 - Ophthalmology
Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Ophthalmology: Retina
ISSN
2468-6530
e-ISSN
2468-6530
Volume of the periodical
9
Issue of the periodical within the volume
4
Country of publishing house
US - UNITED STATES
Number of pages
9
Pages from-to
343-351
UT code for WoS article
001463823000001
EID of the result in the Scopus database
2-s2.0-85208349874