Neovascular Age-Related Macular Degeneration (nAMD) Wet AMDEarly Phase 1NCT07728981
Biomarkers, Effectiveness, and Safety of Aflibercept 8mg Modified Fixed Dose Regimen in Treatment-Naïve nAMD Patients
A Early Phase 1 study testing Aflibercept 8mg in people with Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD, run by Tianjin Medical University Eye Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD
- What is being tested?
- Aflibercept 8mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2026to 31 Dec 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subjects included in this study must meet all of the following ocular inclusion criteria for the study eye:
- Have sufficiently clear ocular media and adequately dilated pupils to obtain high-quality retinal images for diagnosis;
Show all 9Show fewer
- 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.
Who cannot join
- 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 condition that, in the opinion of the investigator, may affect the patient's ability to provide informed consent, comply with the study protocol, complete the study according to study procedures, or for which the patient's participation may affect the study results or their own safety; Exclusion criteria for study eye
- Any eye with diabetic retinopathy (DR), diabetic macular edema (DME), or any retinal vascular disease other than nAMD;
Show all 19Show fewer
- 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);
- Prior periocular or intravitreal drug injections (including anti-VEGF agents) for other retinal diseases;
- Presence of intraocular inflammation/infection in any eye within 12 weeks prior to the screening visit;
- History of idiopathic or autoimmune-related uveitis in the study eye.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Open-Label Phase IV Clinical Study to Evaluate the Biomarkers, Effectiveness, and Safety Based On A Modified Fixed Dose Regimen of Aflibercept 8mg in Treatment-Naïve Patients With Neovascular Age-Related Macular Degeneration (nAMD)
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.
Read the detailed description
Age-related macular degeneration (AMD) is a disease that affects the central part of the retina (the macula) and can lead to loss of central vision in older adults. In developed countries, this condition is the leading cause of central vision loss in this population. AMD has two clinical subtypes: dry and wet (neovascular) forms. The dry type is characterized by progressive accumulation of drusen, with secondary degeneration of the retinal pigment epithelium and photoreceptors; the wet type is characterized by retinal edema and neovascularization, which can lead to severe vision loss. Wet AMD is the main cause of most AMD-related blindness cases.
Inhibiting vascular endothelial growth factor (VEGF) activity with medication has been proven to be an effective therapeutic strategy for treating nAMD. In addition to Eylea® (Aflibercept) injection, multiple anti-VEGF drugs have been approved for nAMD treatment in various countries globally, such as Lucentis® (Ranibizumab), Conbercept, and Faricimab (Vabysmo®). Most nAMD patients require long-term chronic treatment. Although globally approved intravitreal (IVT) anti-VEGF therapies are effective and well tolerated, the need for frequent IVT injections (especially during the maintenance phase) places a significant burden on physicians, patients, and caregivers.
Currently, in China, local reimbursement policies for nAMD cover nine anti-VEGF injections, and patients must bear the cost for any additional treatments. As a chronic progressive disease, nAMD patients typically require longer-term management and more anti-VEGF therapies. Limitations in insurance reimbursement are a primary obstacle in clinical practice.
At the same time, anti-VEGF therapy requires a three-dose loading regimen (once per month), with frequent follow-up and a complex injection schedule, which imposes a significant financial burden on patients, increases treatment costs for physicians, results in low patient adherence, and ultimately reduces long-term visual benefits. A result from the Barometer global survey indicated that 95.2% of physicians and 83.9% of patients believe that improving the predictability of injection timing is the main direction for enhancing patient care.
- Being tested
- Aflibercept 8mg
- Keywords
- Neovascular Age-Related Macular Degeneration, Aflibercept 8mg, Modified Fixed Dose Regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept 8mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-Naïve Patients With nAMD | Experimental | Treatment-Naïve Patients With Neovascular Age-Related Macular Degeneration Receives: Drug: Aflibercept 8mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Proportion of patients who did not receive remedial treatment within 12 months
Measured: From enrollment to the end of treatment at 12 months
best corrected visual acuity (BCVA)
At month 12, the changes in the patient's best corrected visual acuity (BCVA) relative to baseline
Measured: From enrollment to the end of treatment at 12 months
central retinal thickness (CMT)
At month 12, the changes in the patient's central retinal thickness (CMT) relative to baseline
Measured: From enrollment to the end of treatment at 12 months
VEGF-B levels in the patient's aqueous humor
In the second month, the average change in VEGF-B levels in the patient's aqueous humor relative to baseline
Measured: 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
In the second month, the average change in placental growth factor (PIGF) levels in the patient's aqueous humor relative to baseline
Measured: From enrollment to the end of treatment at 0 months、2months、5months、8months、11months
Ang-2 levels in the patient's aqueous humor
In the second month, the average change in Ang-2 levels in the patient's aqueous humor relative to baseline
Measured: From enrollment to the end of treatment at 0 months、2months、5months、8months、11months
IL-6 levels in the patient's aqueous humor
In the second month, the average change in IL-6 levels in the patient's aqueous humor relative to baseline
Measured: From enrollment to the end of treatment at 0 months、2months、5months、8months、11months
IL-8 levels in the patient's aqueous humor
In the second month, the average change in IL-8 levels in the patient's aqueous humor relative to baseline
Measured: From enrollment to the end of treatment at 0 months、2months、5months、8months、11months
Average number of doses in the 12th month
Average number of doses in the 12th month
Measured: "From enrollment to the end of treatment at 12 months
the average area/volume of macular neovascularization (MNV)
At each key visit time point, the relative change from baseline in the average area/volume of macular neovascularization (MNV) in patients ...
Measured: From enrollment to the end of treatment at 0 month、2months、5months、8months、11months
intraretinal fluid (IRF) or subretinal fluid (SRF) in the foveal area
Percentage of patients with no intraretinal fluid (IRF) or subretinal fluid (SRF) in the foveal area at months 0, 2, and 12
Measured: From enrollment to the end of treatment at 2months、12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start25 Jul 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-Related Macular Degeneration (nAMD) Wet AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Eye Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei General Hospital, Shijiazhuang People's Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Shanxi Eye Hospital
- Responsible party
- Principal investigator, Li Xiaorong, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728981
- Sponsor's protocol ID
- 2026KY-31
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No