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Clinical study on retinal arterial macroaneurysms after anti-VEGF therapy in patients using swept-source optical coherence tomographic angiography

Clinical study on retinal arterial macroaneurysms after anti-VEGF therapy in patients using swept-source optical coherence tomographic angiography

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101802
Enrollment
Unknown
Registered
2025-04-29
Start date
2023-12-11
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

retinal arterial macroaneurysm

Interventions

anti-VEGF group:After the initial intravitreal injection of anti-VEGF medication (Conbercept 0.5mg), monthly treatments will be administered based on the retreatment criteria in a pro re nata (PRN) tr
Laser group:To use the traditional laser method

Sponsors

Eye and ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with exudative retinal macroaneurysms (with subfoveal or interretinal effusion, hard exudation, or bleeding) requiring anti-VEGF therapy identified by fluorescence angiography; 2) The symptoms of vision loss attributed to macular edema or hemorrhage; 3) Duration less than 6 months; 4) BCVA >=19 ETDRS letters (Snellen visual acuity 20/400); 5) CRT > 250µm on OCT examination, with macular edema or subretinal fluid; 6) No opacities in the media affecting fundoscopy and no pupillary constriction.

Exclusion criteria

Exclusion criteria: 1) Patients with quiescent retinal artery macroaneurysm (without macular edema or leakage).; 2) Patients with severe vitreous or subretinal hemorrhage and/or secondary macular hole requiring vitrectomy; 3) Patients with active periocular or ocular inflammation in either eye; 4) Presence of any macular disease at baseline that the investigator considers may impact visual recovery; 5) Patients with a history of other diseases causing macular edema; 6) Treatment eyes that have received any prior treatment for macular edema; 7) History of or current uncontrolled glaucoma in either eye; 8) Patients with type I or type II diabetes. 9) History of systemic use of anti-VEGF drugs within the past 6 months prior to screening; 10) Patients with severe asthma, allergies or systemic diseases who cannot undergo fluorescein angiography (FFA) or intravitreal injections; 11) Poorly controlled blood pressure in patients; 12) In the past 6 months prior to screening, patients with severe cardiovascular events such as myocardial infarction, cerebral infarction, active disseminated intravascular coagulation, or marked bleeding tendencies; 13) Patients diagnosed with systemic immunological diseases requiring treatment; 14) Patients currently participating or having participated in other relevant clinical trials in the past 6 months; 15) Patients who refuse or are unable to attend follow-up visits for various reasons; 16) Women of childbearing potential not using effective contraception, pregnant or breastfeeding women. 17) Patients with active psychiatric disorders or other psychological conditions affecting their ability to sign an informed consent form and understand the study; 18) Patients who refuse to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Tumor size;Vascular density ;Best corrected visual acuity;Central retinal thickness;

Countries

China

Contacts

Public ContactWei Liu

Eye and ENT Hospital of Fudan University

bfgf2020@163.com+86 21 6437 7134

Outcome results

None listed

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