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Biomarkers, Effectiveness, and Safety of Aflibercept 8mg Modified Fixed Dose Regimen in Treatment-Naïve nAMD Patients

NCT07728981 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-07-27

No results posted yet for this study

Summary

Primary objective:

• To evaluate the change in aqueous humor vascular endothelial growth factor A (VEGF-A) levels after 2 months of initial treatment with 8 mg Aflibercept in treatment-naïve nAMD patients.

Secondary objectives:

• To assess the efficacy, safety, and biomarker changes of 8 mg Aflibercept using a modified fixed-interval dosing regimen over 12 months in treatment-naïve nAMD patients.

Conditions

  • Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD

Interventions

DRUG

Aflibercept 8mg

All treatment-naïve nAMD patients who have completed screening and meet the eligibility criteria will be included in this study. Aflibercept 8 mg will be administered at Month 0, Month 2, Month 5, Month 8, and Month 11. A rescue treatment follow-up will be conducted at Month 1, and if the criteria for rescue treatment are met, one rescue treatment (Aflibercept 8 mg injection) will be given.

Sponsors & Collaborators

  • Hebei General Hospital

    collaborator OTHER

  • Shijiazhuang People's Hospital

    collaborator OTHER

  • The Affiliated Hospital of Inner Mongolia Medical University

    collaborator OTHER

  • Shanxi Eye Hospital

    collaborator OTHER

  • Tianjin Medical University Eye Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-25
Primary Completion
2026-08-15
Completion
2027-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07728981 on ClinicalTrials.gov