Evidence map›Paper›PMID 38926553›Full record

Trial reportScientific reports2024

Comparison of the efficacy and safety of SCD411 and reference aflibercept in patients with neovascular age-related macular degeneration.

Se Woong Kang, Jaehwan Choi, Veeral S Sheth, Agnieszka Nowosielska, Marta Misiuk-Hojlo, András Papp, David M Brown, Jae-Ho Lee, Yoreh Barak

Abstract readRandomized Controlled TrialMulticenter StudyComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Se Woong Kang *Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. swkang@skku.edu.
Jaehwan Choi *Department of Ophthalmology, Kyung Hee University Medical Center, Kyung Hee University, Seoul, Korea.
Veeral S ShethUniversity Retina and Macula Associates, Lemont, IL, USA.
Agnieszka NowosielskaOphthalmology and Eye Surgery Clinic, Warsaw Eye Hospital, Warsaw, Poland.
Marta Misiuk-HojloDepartment and Clinic of Ophthalmology, Wroclaw Medical University, Wrocław, Poland.
András PappDepartment of Ophthalmology, Semmelweis University, Budapest, Hungary.
David M BrownRetina Consultants of Texas, Houston, TX, USA.
Jae-Ho LeeSamChunDang Pharm. Co. Ltd., Seoul, Korea.
Yoreh BarakDepartment of Ophthalmology, Rambam Health Care Campus, Haifa, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To compare the efficacy and safety of the proposed aflibercept biosimilar SCD411 and reference aflibercept in patients with neovascular age-related macular degeneration, this randomized, double-masked, parallel-group, multicenter study was conducted in 14 countries from 13 August 2020 to 8 September 2022. Patients with neovascular age-related macular degeneration. With subfoveal, juxtafoveal, or extrafoveal choroidal neovascularization were aged 50 years or older. Intravitreal injection of SCD411 or aflibercept (2.0 mg) were administered every 4 weeks for the first three injections and every 8 weeks until week 48. The primary efficacy endpoint was the change in best-corrected visual acuity from baseline to week 8 with an adjusted equivalence margin of ± 3.0 letters. Patients were randomly assigned to receive either SCD411 (n = 288) or reference aflibercept (n = 288). A total of 566 participants (98.3%) completed week 8 of the study. The least-squares mean difference of change in best-corrected visual acuity from baseline to week 8 (SCD411-aflibercept) was - 0.4 letters (90% confidence interval =  - 1.6 to 0.9). The incidence of ocular (69 of 287 [24.0%] vs. 71 of 286 [24.8%]) and serious ocular (5 of 287 [1.7%] vs. 3 of 286 [1.0%]) treatment-emergent adverse effects were similar between the SCD411 and aflibercept groups. Immunogenicity analysis revealed a low incidence of neutralizing antibody formation in both groups. In conclusion, SCD411 has equivalent efficacy compared with reference aflibercept in patients with neovascular age-related macular degeneration and has a comparable safety profile. The results support the potential use of SCD411 for the treatment of neovascular age-related macular degeneration.

Indexed as

Intravitreal InjectionsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVisual AcuityAgedAged, 80 and overAngiogenesis InhibitorsBiosimilar PharmaceuticalsChoroidal NeovascularizationDouble-Blind MethodFemaleHumansMacular DegenerationMaleMiddle AgedTreatment OutcomeafliberceptAngiogenesis InhibitorsBiosimilar PharmaceuticalsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion Proteins

Identifiers

PMID38926553
PMCPMC11208512

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.