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Study on the Changes of Aqueous Humor Cytokines and Imaging Biomarkers in DME Patients Before and After Anti-VEGF Therapy

Study on the Changes of Aqueous Humor Cytokines and Imaging Biomarkers in DME Patients Before and After Anti-VEGF Therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123730
Enrollment
Unknown
Registered
2026-04-29
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Diabetic Macular Edema (DME)

Interventions

Diabetic Macular Edema (DME) Group:None

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=40 years, diagnosed with type 1 or type 2 diabetes mellitus. 2. Confirmed diagnosis of DME, with OCT examination showing CMT > 250 µm or the presence of definite intraretinal cysts. 3. The study eye is either treatment-naïve for anti-VEGF therapy, or has previously received anti-VEGF therapy but discontinued for >=6 months and currently meets the criteria for retreatment. 4. Voluntarily participate in the study and sign the informed consent form. 5. Able to cooperate in completing the OCTA examination and obtain high-quality images (signal strength >=7/10, free from significant motion artifacts).

Exclusion criteria

Exclusion criteria: 1. History of intraocular or periocular glucocorticoid injection within the previous 6 months. 2. History of macular grid laser photocoagulation or panretinal photocoagulation within the previous 3 months. 3. History of intraocular surgery (including cataract surgery) within the previous 3 months, or prior history of vitrectomy. 4. Presence of other ocular diseases that may cause macular edema, such as retinal vein occlusion, uveitis, neovascular age-related macular degeneration, etc. 5. Severe media opacity affecting OCT/OCTA image quality assessment (e.g., significant cataract, vitreous hemorrhage). 6. Presence of uncontrolled severe systemic diseases (e.g., uncontrolled hypertension, recent cardiovascular or cerebrovascular events). 7. Presence of ocular conditions that may affect OCTA signal quality (e.g., significant nystagmus, poor fixation).

Design outcomes

Primary

MeasureTime frame
Central Macular Thickness, CMT;Best Corrected Visual Acuity (BCVA);

Secondary

MeasureTime frame
Concentration of cytokines in aqueous humor, imaging biomarkers such as SRF and DCP;

Countries

China

Contacts

Public ContactQing Peng

Shanghai Tenth People's Hospital

drqingpeng@126.com+86 21 6630 1715

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026