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A Study on the Construction of a Predictive Model for the Efficacy of Anti-VEGF Drug Therapy in Diabetic Macular Edema Based on OCTA Radiomics

A Study on the Construction of a Predictive Model for the Efficacy of Anti-VEGF Drug Therapy in Diabetic Macular Edema Based on OCTA Radiomics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108868
Enrollment
Unknown
Registered
2025-09-08
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

diabetic macular edema

Interventions

Anatomical improvement sensitive group (?CRT > 50 µm), anatomical improvement insensitive group (?CRT <=50 µm):None

Sponsors

Shanghai Sixth People's Hospita
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age >=18 years old; Confirmed DME (OCT confirmed: macular central retinal thickness (CRT) measured by OCT >=250µm); Complete three basic injections +PRN anti-VEGF treatment; Complete baseline and follow-up OCTA data are available.

Exclusion criteria

Exclusion criteria: 1. Combined with other eye diseases such as retinal vein occlusion, age-related macular degeneration, macular hole, uveitis, glaucoma, etc. 2. Those who have undergone cataract surgery within the past two months; 3. Those who have a history of vitrectomy or other ophthalmic surgeries; 4. Those who have been treated with other treatment regimens for DME, such as intravitreal or retrobulbar injection of glucocorticoids. 5. Uncontrolled hypertension or poor blood sugar control with glycated hemoglobin > 12%; 6. A cerebrovascular accident or myocardial infarction has occurred within the past three months.

Design outcomes

Primary

MeasureTime frame
Changes in the thickness of the macular fovea retina;

Secondary

MeasureTime frame
Change in best corrected visual acuity;The mean blood flow density (VD) of the superficial retinal capillary cluster (SCP) and the deep retinal capillary cluster (DCP);Retinal outer layer blood flow density (ORVD) in the macular area;Choroidal capillary layer blood flow density ;Retinal capillary non-perfusion area (RNPA);Choroidal vascular index (CVI);Parameters of the foveal avascular zone (FAZ);Thickness variation of GCC;Hyperreflective foci within the retina;Disorder of the inner layer structure of the retina;Ellipsoid zone - continuity of the outer membrane;Perioptic disc blood flow index (PFI);Thickness of the retinal nerve fiber layer around the optic disc;The number of neovascularization in the optic disc;

Countries

China

Contacts

Public ContactJin Yanling

Shanghai Sixth People's Hospita

jinyanling2014@163.com+86 181 1601 0991

Outcome results

None listed

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