Skip to content

A single-center, observational, cohort study to evaluate the real-world efficacy and safety of faroxizumab injection in patients with newly diagnosed diabetic macular edema

A single-center, observational, cohort study to evaluate the real-world efficacy and safety of faroxizumab injection in patients with newly diagnosed diabetic macular edema

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120290
Enrollment
Unknown
Registered
2026-03-11
Start date
2026-03-11
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic macular edema

Interventions

Diabetic macular edema observation group:None

Sponsors

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old, gender not restricted, and signed informed consent; 2. Clinically diagnosed with DME; 3. Received Fasrelizumab treatment (loading period + T&E) and underwent follow-up and clinical assessment; 4. Before the initial injection, no any DME-related treatment was received; 5. There is a relatively complete assessment of DME disease.

Exclusion criteria

Exclusion criteria: 1. Patients who did not receive Fasrice antibody treatment as per the instructions; 2. Other exudative macular diseases, severe cataracts, etc.; 3. Other ocular diseases such as glaucoma and uveitis that affect the treatment plan; 4. Severe systemic diseases (advanced cancer, renal failure, etc.); 5. Poor OCTA imaging due to unclear refractive media, eye movement, etc.; 6. Previous history of intraocular surgery (such as vitrectomy surgery, etc.); 7. Those with 80% incomplete clinical records of injection, clinical assessment and follow-up within 12 months; 8. Those who had no OCT scan data at baseline and the last follow-up, or the OCT scan area centered on the fovea was not 6mm*6mm.

Design outcomes

Primary

MeasureTime frame
Subretinal fluid;Intraretinal fluid ;Hyperreflective foci;External limiting membranes;Ellipsoid zone ;

Secondary

MeasureTime frame
Inflammation cytokines;

Countries

China

Contacts

Public ContactDong Wentao

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

dongwentao@med.uestc.edu.cn+86 177 0812 7007

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026