Diabetes macular edema (DME) and wet age-related macular degeneration (wAMD)
Conditions
Interventions
wAMD group:None
Sponsors
Inner Mongolia Chaoju Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Voluntary signing of informed consent form (ICF); 2.Chinese female or male patients diagnosed with wAMD or DME through CFP, OCT, FFA, ICGA, or OCTA; 3.At the time of signing the informed consent form (or the first treatment with Zhuochuming, whichever occurs first), wAMD patients>50 years old and DME patients>18 years old; 4.The decision of the patient to receive treatment with Zhuo Chuming was made before and independently of the study; 5.The research eye has received at least one treatment with Zhuochuming (i.e. completed the first administration)..
Exclusion criteria
Exclusion criteria: 1. Patients who have not received treatment with Zocor according to standard therapy and the current Product Characteristic Summary (SPC)/Chinese instructions; 2. Patients with active ocular inflammation or suspected/active ocular infection in either eye; 3. Patients who have received any other anti-VEGF treatment after receiving Zocor; 4. Patients whose study eye received any steroid treatment within 6 months (180 days) prior to the first Zocor treatment; 5. Patients currently participating in any other clinical trial; 6. Patients unable to provide baseline clinical data (vision and OCT images) within 2 weeks (14 days) before the first Zocor treatment; 7. Study eyes with eye diseases affecting fundus observation and optical coherence tomography (OCT) examination, such as significant corneal disease, severe cataract, or vitreous hemorrhage; 8. Patients with systemic conditions unsuitable for surgery, such as myocardial infarction or cardiovascular/cerebrovascular diseases within the past 6 months, or severe systemic diseases; 9. Female patients who are breastfeeding or pregnant; 10. Patients allergic to the study drug or excipients; 11. Patients who have participated in other drug clinical trials within the past 3 months; 12. Other conditions deemed unsuitable for participation in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VA (approximately ETDRS letter score 1) from baseline at month 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| VA at baseline and at months 3, 6, 9, and 12 (approximate ETDRS letter score 1);Changes in VA (approximately ETDRS letter score 1) from baseline at months 3, 6, and 9;CRT at baseline, 3, 6, 9, and 12 months;Changes in CRT from baseline at months 3, 6, 9, and 12;Safety Indicators: Adverse Events (AEs); | — |
Countries
China
Contacts
Public ContactGuisen Zhang
Inner Mongolia Chaoju Eye Hospital
Outcome results
None listed