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A multicenter, single arm clinical trial of intravitreal injection of Aflibercept in patients with neovascular age-related macular degeneration complicated with type I choroidal neovascularization with low response to ranibizumab or Conbercept

A multicenter, single arm clinical trial of intravitreal injection of Aflibercept in patients with neovascular age-related macular degeneration complicated with type I choroidal neovascularization with low response to ranibizumab or Conbercept

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057703
Enrollment
Unknown
Registered
2022-03-15
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

Neovascular age-related macular degeneration (nAMD)

Interventions

Intervention group:Injection of Aflibercept

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years; 2. nAMD with type I CNV was diagnosed by OCT and FFA, and active CNV was confirmed by OCTA; 3. At least 4 intravitreal injections of leizumab or compacept were received in the 6 months before dressing change, and IRF or SRF remained persistent under OCT after two consecutive injections; 4. BCVA is less than or equal to 73 letters; 5. Patients agree to participate in clinical trials and sign informed consent; 6. Patients were able to participate in the treatment and the 12 month follow-up period.

Exclusion criteria

Exclusion criteria: 1. The patient had contraindications to abercept, including eye and periocular infection, active intraocular inflammation, etc.; 2. There are other eye diseases that may affect the patient's vision; 3. History of vitreoretinal surgery, including scleral buckling; 4. History of cataract surgery within 90 days; 5. To investigate macular central structural damage in the eyes that may hinder BCVA improvement, including retinal pigment epithelial atrophy, subretinal fibrosis or scarring; Those who were assessed as mature CNV by OCTA examination before enrollment; 6. Intraocular pressure of study eye >=25 mmHg; 7. High myopia prior to refractive surgery or cataract surgery; 8. Pregnant or lactating patients; 9. On hormonal or immunosuppressive therapy; 10. Patients with active infections and autoimmune diseases, including hepatitis B, hepatitis C, systemic lupus erythematosus, etc.; 11. Known sensitivities to possible therapeutic agents (patients allergic to appercept or excipients); 12. Patients with incomplete functions of heart, liver, kidney and other important organs; 13. Concurrent treatment with experimental drugs or devices in other clinical studies; 14. The investigator considered that the patient had other conditions that were not suitable for the study.

Design outcomes

Primary

MeasureTime frame
best corrected visual acuity;intraocular pressure;optical coherence tomography;optical coherence tomography angiography;fundus angiography;number of Aflibercept injections;adverse reactions;

Countries

China

Contacts

Public ContactZhang Meixia

West China Hospital of Sichuan University

zhangmeixia@scu.cn+86 18980602236

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026