proliferative diabetic retinopathy
Conditions
Interventions
control group:0.5mg ranibizumab injection after PPV
experimental group:1.0mg ranibizumab injection after PPV
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged >=18 years old with diabetes mellitus (type 1 or type 2), newly diagnosed as proliferative diabetic retinopathy, with retinal traction detachment or continuous vitreous hemorrhage and never received PPV before; 2. The visual acuity of the taget eyes must be attributed to severe PDR; 3. The best corrected visual acuity of ETDRS was 0-73 letters; 4. Be willing to participate in the clinical experiment and sign the informed consent form; 5. Be willing to follow up according to the protocol.
Exclusion criteria
Exclusion criteria: 1. Systemic diseases are not controlled; 2. Patients who have severe PDR with extensive retinal plica, requiring retinotomy or have extensive retinal traction detachment or retinal hole; 3. Patients who have received systemic anti VEGF or VEGF treatment within 3 months before randomization; 4. Intraocular or periocular surgery was performed within 3 months(including laser photocoagulation, cataract surgery, etc.) 5. Patients who have other serious eye diseases besides DR, such as uveitis, retinal vascular changes, congenital and traumatic vitreoretinopathy; 6. Patients who have contraindications to PPV, such as severe hypertension, poor blood glucose control, abnormal liver and kidney function, allergic anesthesia and other general conditions are not allowed; 7. Patients who have contraindications to anti VEGF drugs, such as active infection of the eye or periocular and active endophthalmitis; 8. Patients who had participated in other clinical trials within 3 months before the group was enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCVA; | — |
Secondary
| Measure | Time frame |
|---|---|
| vitreous hemorrhage;Time from entering the study to completly removal of vitreous hemorrhage;Adverse events recorded during treatment; | — |
Countries
China
Contacts
Public ContactQinghua Qiu
Shanghai General Hospital
Outcome results
None listed