NCT07640997 Real-world Study of Aflibercept 8 mg in nAMD
| NCT ID | NCT07640997 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | Neovascular Age-Related Macular Degeneration (nAMD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-11-11 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-11-11 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to explore the effectiveness of aflibercept 8 mg in treating both treatment-naive and previously treated patients with neovascular age-related macular degeneration (nAMD) in a real-world setting. The main questions it aims to answer are: What are the short-term and long-term efficacy outcomes of aflibercept 8 mg in treatment-naive or previously treated nAMD patients? What are the safety characteristics and the treatment patterns of aflibercept 8 mg in these patient populations? Participants will: Receive aflibercept 8 mg as part of their clinical treatment for nAMD. Undergo assessments to evaluate both the efficacy and safety of the treatment over the short and long term. Provide data on their visual acuity (BCVA) changes at multiple follow-up points (4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months). Report any adverse events and treatment patterns during the study period. Have their central subfield thickness (CST) measured at specified intervals. This study will help inform clinical practices regarding the use of aflibercept in nAMD patients and contribute to understanding its effectiveness and safety in real-world settings.
Eligibility Criteria
Inclusion Criteria: * Patient aged ≥50 years * A diagnosis of nAMD * Signed informed patient consent before the start of data collection * Patients for whom the decision to initiate treatment with IVT aflibercept 8 mg according to a local product information was made as part of routine clinical practice Exclusion Criteria: * Participation in an investigational program with interventions outside of clinical routine practice * Contraindications as listed in the intravitreal aflibercept 8 mg local product information (Ocular or periocular infections, severe active intraocular inflammation, and known allergy to aflibercept or any of its excipients) * The fellow eye has received intravitreal anti-VEGF treatment other than aflibercept within 28 days prior to enrollment * Intraocular pressure (IOP) in the study eye \> 25 mmHg * Additional exclusion criteria for naïve nAMD patients: * Any prior ocular treatment in the study eye or systemic treatment for nAMD * Additional exclusion criteria for pretreated nAMD patients: * Prior intravitreal anti-VEGF treatments in the study eye within the last 28 days * Prior treatment with intravitreal corticosteroid in the study eye within the last 3 months * Dexamethasone implant in the study eye within the last 6 months * Any concurrent drug releasing implant in the study eye
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07640997 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Neovascular Age-Related Macular Degeneration (nAMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07640997 currently recruiting?
Yes, NCT07640997 is actively recruiting participants. Contact the research team at dr_zhaomingwei@163.com for enrollment information.
Where is the NCT07640997 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT07640997 clinical trial?
NCT07640997 is sponsored by Peking University People's Hospital. The trial plans to enroll 300 participants.