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

NCT07728981 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2026KY-31
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Neovascular Age-Related Macular Degeneration; Aflibercept 8mg; Modified Fixed Dose Regimen

Outcome Measures

Primary Outcomes (1)

• VEGF-A levels in the patient's aqueous humor

  In the second month, the average change in VEGF-A levels in the patient's aqueous humor relative to baseline

  From enrollment to the end of treatment at 0 months、2months、5months、8months、11months

Secondary Outcomes (11)

• Proportion of patients who did not receive remedial treatment

  From enrollment to the end of treatment at 12 months

• best corrected visual acuity (BCVA)

  From enrollment to the end of treatment at 12 months

• central retinal thickness (CMT)

  From enrollment to the end of treatment at 12 months

• VEGF-B levels in the patient's aqueous humor

  From enrollment to the end of treatment at 0 months、2months、5months、8months、11months

• placental growth factor (PIGF) levels in the patient's aqueous humor

  From enrollment to the end of treatment at 0 months、2months、5months、8months、11months

Study Arms (1)

Treatment-Naïve Patients With nAMD

EXPERIMENTAL

Treatment-Naïve Patients With Neovascular Age-Related Macular Degeneration

Drug: Aflibercept 8mg

Interventions

Aflibercept 8mg DRUG

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.

Treatment-Naïve Patients With nAMD

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who fully understand the content, procedures, and possible adverse events (AEs) of this study and are able to provide written informed consent;
• Male or female patients aged ≥50 years at the time of signing the informed consent;
• Women of childbearing potential (WOCBP) must agree to use dual contraception during the study and for 4 months after discontinuation of study treatment, consisting of one medically recognized contraceptive method with a failure rate of less than 1% per year (see Appendix 1 for Contraceptive Measures, Definitions and Requirements for Women of Childbearing Potential) combined with a barrier method (e.g., condom). Women who have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or menopause for more than 1 year are considered not of childbearing potential. Women of childbearing potential must have a negative pregnancy test at screening and must not become pregnant, breastfeed, lactate, or plan pregnancy, breastfeeding, or egg donation during the study and for 4 months after discontinuation of study treatment;
• Male subjects whose partners are of childbearing potential must agree to use dual contraception during the study and for 4 months after the end of treatment, consisting of one medically recognized contraceptive method with a failure rate of less than 1% per year (see Appendix 1 for Contraceptive Measures, Definitions and Requirements for Women of Childbearing Potential) combined with a barrier method (e.g., condom), and must agree not to donate sperm during the study and for 4 months after the end of treatment.
• Have sufficiently clear ocular media and adequately dilated pupils to obtain high-quality retinal images for diagnosis;
• Untreated nAMD with active subfoveal choroidal neovascularization (CNV), with total CNV area accounting for more than 50% of the total lesion area.
• SD-OCT examination showed the presence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) in the foveal center of the retina.
• During the screening and baseline periods, BCVA scores measured using the ETDRS visual acuity chart at an initial testing distance of 4 meters ranged from 78 to 24 ETDRS letters (inclusive) (approximately equivalent to Snellen visual acuity 20/32 to 20/320), and the vision loss was caused by nAMD.

You may not qualify if:

• Patients who have received other investigational treatments (including anti-VEGF, corticosteroids, laser photocoagulation treatments \[panretinal photocoagulation or macular photocoagulation\], and photodynamic therapy \[PDT\]) or approved nAMD drugs/therapies;
• Patients with allergies or hypersensitivity reactions to any component/excipient of the investigational product;
• Uncontrolled hypertension (defined as systolic blood pressure \>160 mmHg or diastolic blood pressure \>95 mmHg). Subjects may be treated with up to three known antihypertensive drugs to achieve adequate blood pressure control. This restriction applies to drugs that can be used for treating hypertension, even if the primary purpose of taking the drug for the subject is not blood pressure control. Any medication known to affect blood pressure must have a stable regimen for 12 weeks prior to screening;
• History of other diseases, metabolic dysfunctions, abnormal physical examinations, or clinical laboratory abnormalities that reasonably suggest a contraindication to the investigational drug, may interfere with the interpretation of study results, or could place the patient at high risk for treatment-related complications;
• Any eye with diabetic retinopathy (DR), diabetic macular edema (DME), or any retinal vascular disease other than nAMD;
• Presence of extraocular/periocular infection or inflammation in any eye during the screening or baseline period;
• Presence of retinal pigment epithelium (RPE) tear or rupture, scarring, fibrosis, or atrophy involving the fovea;
• Fluorescein angiography (FA)/fundus photography (FP) showing:
• Total lesion area (including hemorrhage, scarring, and neovascularization) greater than 12 disc areas (30.5 mm²);
• Fibrosis or atrophy \>50% of the total lesion area, and/or involving the fovea.
• Any intraocular disease that the investigator believes may reduce vision improvement or require medical or surgical intervention during the study (such as amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, epiretinal membrane with traction):
• Presence of vitreous hemorrhage during the screening or baseline period;
• Uncontrolled glaucoma (intraocular pressure still \>25 mmHg despite anti-glaucoma medication);
• Any cataract surgery or treatment for cataract surgery complications with steroids or yttrium-aluminum garnet (YAG) laser capsulotomy within 3 months prior to Day 1 of the study;
• Any prior intraocular surgery (e.g., vitrectomy, glaucoma surgery, corneal transplantation, or radiation therapy);

Sponsors & Collaborators

• Tianjin Medical University Eye Hospital: lead
• Hebei General Hospital: collaborator
• Shijiazhuang People's Hospital: collaborator
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator
• Shanxi Eye Hospital: collaborator

MeSH Terms

Interventions

aflibercept

Central Study Contacts

Xinjun Ren, PHD

CONTACT

+86 13902067301; zlrxjrsy@126.com

Shoukuan Liu, master

CONTACT

17694924913; lsk1530407426@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 27, 2026
• Study Start: July 25, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share