Age-related macular degeneration
Conditions
Interventions
Observation group:None
Sponsors
Xi 'an People's Hospital (Xi 'an Fourth Hospital)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient provides full voluntary consent and signs an informed consent form; 2. The patient is at least 50 years of age at the time of informed consent (or at the time of the first injection of fariciclib, whichever occurs earlier); 3. The patient is a Chinese male or female diagnosed with neovascular age-related macular degeneration (nAMD); 4. The patient has not received any anti-VEGF therapy in the three months prior to the first injection of fariciclib; 5. The patient is able to cooperate with the treatment process and the 12-month follow-up period; 6. At baseline, OCTA clearly detects macular neovascularization (MNV), and high-quality OCTA data is available at the time of treatment initiation.
Exclusion criteria
Exclusion criteria: 1. Any active ocular inflammation or suspected/active ocular infection present in either eye; 2. Secondary CNV caused by other diseases, or neovascular age-related macular degeneration (nAMD) presenting as type 3 MNV; 3. Retinal pigment epithelial detachment, subretinal fibrosis, or atrophy in the study eye; 4. History of vitrectomy in the study eye or any other active ocular disease affecting the retina, such as uncontrolled glaucoma or uveitis; 5. Presence of other retinal vascular diseases besides nAMD, or any ocular conditions affecting vision in the study eye or impairing retinal examination; 6. Having undergone photodynamic therapy (PDT) or transretinal thermal therapy (TTT) in the study eye within the past 90 days; 7. Patients currently taking systemic medications (such as steroids, anti-VEGF agents) or other potentially retinotoxic drugs that may affect the efficacy of fariciclib; 8. Patients participating in any other interventional clinical trial; 9. Patients deemed unsuitable for inclusion in this study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average change of MNV area (mm^2) compared with baseline at 12th week.; | — |
Secondary
| Measure | Time frame |
|---|---|
| MNV maturity;Vascular density (VD);Total vascular area (VD);Fractal Dimension(FD);Lacunar (Heterogeneous);Choriocapillary Blood Flow;Perfusion Density (PD);Central Retinal Thickness (CRT);Effusion Resolution Rate;Choroidal Thickness (CT);Visual Acuity;Cumulative injection times in the 24th and 48th weeks.;Proportion of patients who reach the extended interval of administration (>= 12 weeks, >=16 weeks); | — |
Countries
China
Contacts
Public ContactZhang Yanchun
Xi 'an People's Hospital (Xi 'an Fourth Hospital)
Outcome results
None listed