Diabetic retinopathy
Conditions
Interventions
Fariximab Group:None
Fusion Protein Drug Group:None
Sponsors
The Second Affliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old, gender not limited; 2. Clinically diagnosed as proliferative diabetic retinopathy (PDR), with active neovascularization present; 3. Patients may or may not have diabetic macular edema. 4. Allow the patient to have received anti-VEGF treatment three months ago; 5. During the screening period, the diabetes of the patients was well controlled, and the glycated hemoglobin was =10% within 2 months before the first medication. 6. The best corrected visual acuity (BCVA) measured for the study eyes using the LogMAR visual acuity chart was 0.3 to 1.20 (equivalent to Snellen visual acuity 20/40 to 20/320). 7. Fertile women should take effective contraceptive measures during the study drug treatment period and for at least 3 months after the last use of the study drug. 8. The patient or his/her legal representative can understand and sign the informed consent form, and is willing to abide by the follow-up and treatment plan stipulated in the research protocol. Note: Each subject can only be selected for one study eye in the research. If both eyes of the subject meet the inclusion criteria, it is recommended that the researcher give priority to the eye with poorer vision for the study.
Exclusion criteria
Exclusion criteria: 1. There is active infection of the eye or around the eye (such as conjunctivitis, keratitis, blepharitis) or active intraocular inflammation (such as uveitis); 2. The studied eye had tractional retinal detachment involving the fovea centralis of the macula, and the researchers believed that vitrectomy surgery should be performed immediately. 3. The study eye has severe medium opacity that affects fundus imaging or assessment (such as severe cataract, corneal leukoma, and dense vitreous hemorrhage that cannot be absorbed); 4. Poor blood pressure control (defined as a systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg when the patient is at rest); 5. Patients who are known to be allergic to faroxizumab, ranibizumab, aflibercept, conbercept or any excipients; 6. Patients who developed renal failure requiring kidney transplantation, hemodialysis or peritoneal dialysis within 6 months prior to the screening period, or who are expected to require hemodialysis or peritoneal dialysis at any time during the study period; 7. Stroke (cerebrovascular accident) or myocardial infarction occurs within 6 months; 8. The study eye has uncontrollable glaucoma (defined as intraocular pressure remaining above 25 mmHg after treatment with anti-glaucoma drugs); 9. The study eyes have received panretinal laser photocoagulation (PRP) treatment within 3 months (except for focal/grid photocoagulation); 10. The study eye has received intraocular corticosteroid injection or implantation within one month; 11. Pregnant or lactating women; 12. Researchers who, for other reasons, are deemed unsuitable for inclusion in this item.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retinal Neovascularization Area;Retinal Non-perfusion Area;Average Blood Flow Density in Macular Area; | — |
Secondary
| Measure | Time frame |
|---|---|
| Retinal Neovascularization Area;Retinal Non-perfusion Area;Average Blood Flow Density in Macular Area;Central Macular Thickness;Best Corrected Visual Acuity; | — |
Countries
China
Contacts
Public ContactZhang Zhongyu
The Second Affliated Hospital of Harbin Medical University
Outcome results
None listed