Center-involved Diabetic Macular Edema (CI-DME)
Conditions
Interventions
Treat-and-Extend (T&E) Regimen Group:None
Pro Re Nata (PRN) Regimen Group:None
Sponsors
Hebei Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntarily signs the Informed Consent Form (ICF); 2.Willing to comply with the treatment and follow-up procedures involved in the study; 3.Age >= 18 years, regardless of gender; 4.Type 1 or Type 2 diabetes mellitus; and HbA1c 300 µm; 6.Best Corrected Visual Acuity (BCVA) in the study eye is between 78 and 24 letters, inclusive (approximate Snellen equivalent of 20/32 to 20/320), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart; 7.Patients who are intended to receive intravitreal (IVT) injection of aflibercept (Zhuochuming), including both treatment-naïve and previously treated patients.
Exclusion criteria
Exclusion criteria: 1.Known allergy or contraindication to the active ingredient or any excipients of the study drug; 2.Macular edema in either eye due to any cause other than diabetes; 3.The study eye has Proliferative Diabetic Retinopathy (PDR); 4.Intravitreal injection of any anti-Vascular Endothelial Growth Factor (VEGF) agent (e.g., aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) in the study eye within 12 weeks prior to screening; 5.Use of intraocular or periocular corticosteroids in the study eye within 16 weeks prior to screening; 6.Systemic anti-VEGF therapy within 6 months prior to the screening visit; 7.Prior use of ocriplasmin in the study eye; 8.Presence of any severe clinical conditions such as Acquired Immune Deficiency Syndrome (AIDS), malignancy, or poorly controlled severe psychiatric, neurological, cardiovascular, respiratory, or urinary system diseases; 9.History of myocardial infarction, unstable angina, and/or stroke within 6 months prior to screening; or presence of thromboembolic disease, active disseminated intravascular coagulation, or a significant bleeding tendency; 10.Women who are pregnant, lactating, or planning to become pregnant within 6 months; or male patients whose partners plan to become pregnant within 6 months; or subjects unwilling to use a medically approved, effective method of contraception (e.g., intrauterine device or condom) during the study; 11.Clinically unstable condition prior to enrollment, or evidence of abnormal, clinically significant laboratory findings that, in the investigator's judgment, make the subject unsuitable for the study; 12.Previous participation in a clinical trial of any investigational new drug administered via intravitreal injection; 13.Any condition which, in the judgment of the investigator, would make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in BCVA at 12 months: Change in best-corrected visual acuity (BCVA) of the study eye from baseline to Month 12 (results from different testing methods converted to approximate Early Treatm; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in CRT at 12 months: Change in central retinal thickness (CRT) of the study eye from baseline to Month 12;;Total number of injections: Cumulative injections of the study drug in the affected eye from enrollment to end of treatment;;incidence rate of adverse reactions;Total number of follow-up visits: Cumulative patient follow-up visits (including evaluation-only and treatment visits) from enrollment to end of treatment;;Transportation costs: Total round-trip travel expenses for hospital follow-ups/treatments from enrollment to end of treatment;;Medical expenses: Total patient expenditures for the study drug (including registration, medication, injection, and examination fees) from enrollment to end of treatment;;Mean change in BCVA at 5 months: Change in BCVA of the study eye from baseline to Month 5;;Quality of life: Change from baseline in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) score at Month 12.;Time cost: Total time required for hospital follow-ups/treatments (including travel, examination, and consultation time) from enrollment to end of treatment;; | — |
Countries
China
Contacts
Public ContactWang Lifei
Hebei Eye Hospital
Outcome results
None listed