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The effect of "4+PRN" anti-VEGF treatment on diabetes macular edema based on systematic management: a prospective cohort study

The effect of "4+PRN" anti-VEGF treatment on diabetes macular edema based on systematic management: a prospective cohort study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080441
Enrollment
Unknown
Registered
2024-01-29
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

diabetes macular edema

Interventions

intervention group:"4+PRN"Aflibercept treatment based on "in-person-remote" whole course self-management support model
control group:"4+PRN"Aflibercept treatment based on Traditional outpatient management

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: ? The patient's age is = 18 years old and = 70 years old; ? Patients who agree to accept Internet plus diabetes co care model online diabetes self-management support; ? Type 2 diabetes patients; ? Patients confirmed by ophthalmology to have moderate or severe non proliferative phase with monocular or binocular ci-DME requiring anti VEGF treatment; ? Voluntarily sign an informed consent form before conducting the study.

Exclusion criteria

Exclusion criteria: ? Retinal and choroidal diseases, such as retinal vascular obstructive disease, macular edema, macular membrane, macular hole, age-related macular degeneration, uveitis, etc; ? Eye pressure>21 mmHg (1 mmHg=0.133 kPa), or presence of glaucoma, suspected glaucoma, high intraocular pressure, or other optic nerve diseases; ? Diopter>+5.0 D or26 mm or<21 mm; ? Refractive interstitial opacity that affects the image quality of fundus examination or OCTA and OCT examinations; ? A history of intraocular surgery, such as intravitreal injection, retinal photocoagulation, vitreoretinal surgery, glaucoma surgery, etc., other than a history of cataract phacoemulsification surgery for at least one year after surgery; ? History of ocular trauma; ? Neurological diseases, such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc; ? Systemic diseases, such as severe cardiovascular diseases, blood diseases, rheumatic and immune diseases, etc; ? Pregnant and postpartum women; ? Patients who cannot be matched or completed the study; ? Patients diagnosed by physicians with psychological and psychiatric disorders.

Design outcomes

Primary

MeasureTime frame
ETDRS vision;Macular fovea thickness;

Secondary

MeasureTime frame
Implementation rate of structured diagnosis and treatment of diabetes;Execution rate of structured management in ophthalmology;Control rate of metabolic indicators in systematic management of diabetes;Renal composite endpoint;Secondary endpoint of ophthalmic management;

Countries

China

Contacts

Public ContactLi Ang; Hao Jianchen

Peking University First Hospital

liang850513@hotmail.com+86 136 8133 8795

Outcome results

None listed

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