ArticleOphthalmology and therapy2025
Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial.
Article in Ophthalmology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04739306 (A Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
Who cites it
1 citing paper in PubMed.
- Biosimilars of anti-VEGF agents in retinal diseases: a narrative review of regulatory, clinical, and pharmacoeconomic aspects.International journal of retina and vitreous · 2026Review
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionA 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.
methodsThis 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 ≥ 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.
resultsOverall, 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.
conclusionsResults through week 52 support the therapeutic equivalence between CT-P42 and reference aflibercept by demonstrating comparable long-term efficacy, safety, and immunogenicity.
trial registrationClinicalTrials.gov identifier: NCT04739306.
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