AI-Driven Multimodal AO/SS-OCT Imaging for Evaluating Therapeutic Response to Intravitreal Anti-VEGF in Diabetic Macular Edema

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600123899

Enrollment

Unknown

Registered

2026-04-30

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

Interventions

Diabetic Macular Edema group:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age: 18 years or older with confirmed diagnosis of diabetes mellitus (type 1 or 2). 2. DME Diagnosis: Meets international diagnostic criteria for diabetic macular edema (DME), with central macular thickness (CMT) =300 µm (measured by optical coherence tomography, OCT). 3. Imaging Findings: Swept-source OCT (SS-OCT) reveals DME features such as retinal thickening, cystoid edema, or hard exudates; or OCT angiography (OCTA) demonstrates capillary dropout, microaneurysms, or retinal non-perfusion areas. 4. Treatment Requirement: Requires anti-VEGF therapy (Conbercept) and agrees to the 3+PRN regimen (3 initial monthly injections followed by pro re nata treatment). 5. Visual Acuity Range: Best-corrected visual acuity (BCVA) between 0.05 and 0.5. 6. Good Systemic Condition: Able to complete a 2-year follow-up with good compliance. 7. Informed Consent: Patients or legal guardians fully understand the study protocol and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Coexisting ocular diseases: Including severe diabetic retinopathy, prior vitrectomy, or other ocular conditions affecting macular structure and active ocular inflammation (e.g., retinal vein occlusion, uveitis). 2. Systemic comorbidities: Patients with severe systemic diseases that may compromise study participation and follow-up, such as myocardial infarction or stroke within the past 6 months, HIV infection, active tuberculosis. 3. Imaging quality limitations: Conditions preventing acquisition of clear imaging (e.g., dense cataracts, nystagmus). 4. Compliance concerns: Inability to comply with long-term follow-up or unwillingness to accept 3+PRN anti-VEGF treatment regimen.

Design outcomes

Primary

Measure	Time frame
Predictive Accuracy of Visual Acuity Improvement;Predictive Accuracy of Central Macular Thickness (CMT) Changes;	—

Secondary

Measure	Time frame
Predictive Accuracy of Anti-VEGF Response;Predictive Accuracy of Fluid Accumulation (IRF/SRF);	—

Countries

China

Contacts

Public ContactZhaoyang Wang

Bejing Tongren Hospital, Capital Medical Uniersity

zhaokekewzy@hotmail.com+86 15921108602

Outcome results

None listed

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