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Real-world Study of Aflibercept 8 mg in nAMD

Recruitingn/aAges 50 Years - anyAllPeking University People's Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patient aged โ‰ฅ50 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 naรฏve 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
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What it tests

  • Aflibercept 8mg
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Where

27 sites
Peking University People's Hospital
Beijing, China
Beijing CHAO-YANG Hospital, Capital Medical University
Beijing, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Haidian Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, China

โ€ฆand 19 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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