Proliferative Diabetic retinopathy
Conditions
Interventions
Preoperative group:Intravitreal injection of Conbercept before PPV + PPV
Postoperative group:Intravitreal injection of Conbercept at the end of PPV+PPV
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign informed consent form and agree to follow-up according to the sheduled time; 2. Age is greater than or equal to 18 years old, regardless of sex; 3. Diagnosed as type 2 diabetes. 4. Glycated hemoglobin A1c (HbA1c) value is less than or equal to 10%; 5. Non-absorbable vitreous hemorrhage caused by PDR in the study eye for at least 2 weeks; 6. The BCVA of the study eye measured by the international standard logarithmic visual acuity chart at a distance of 4m/1m is light perception to 0.3 logMAR (equivalent to 0.5 of decimal visual acuity); Note: if both eyes of the subject meet the inclusion criteria, the investigator will decide which one to be included.
Exclusion criteria
Exclusion criteria: 1. Subjects with any of the following eye diseases: (1) Any eye has active eye infection (such as blepharitis, keratitis, scleritis, conjunctivitis, etc.); (2) In addition to DME, the study eye also suffers from other ophthalmic conditions that lead to retinopathy, maculopathy or visual acuity changes (such as retinal vein occlusion (RVO), CNV, macular hole, etc.); (3) The study eye has traction retinal detachment involving or threatening macula; (4) The study eye has glaucoma or has a history of glaucoma filtration surgery; (5) The investigators believe that the cataract of the study eye may affect the judgment of the examination or study results, or the subjects plan to receive cataract surgery in the next month; (6) The study eye has no (artificial) lens; (7) The study eye has severe proliferation and is not suitable for anti-VEGF treatment; (8) The study eye is pathological myopia (defined as axial length is greater than or equal to 26.5mm and corneal diopter is greater than or equal to 6.00D) Note: if the subject is confirmed to have RVO-ME during operation, there is no need to withdraw from the group. Add diagnostic instructions after operation and continue to agree to follow-up according to the protocol. 2. Those who have any of the following treatments of eye diseases: (1) The study eye has undergone PPV surgery before screening; (2) The study eye has received any medicated intraocular implant (such as dexamethasone ocular implant) within 6 months before screening; (3) The study eye has been treated with anti-VEGF drugs (such as conbercept, pegaptanib sodium, ranibizumab, bevacizumab, etc.) within 2 months before screening; (4) The study eye has undergone any other intraocular surgery (such as cataract surgery, YAG laser posterior capsular dissection, etc.) within 4 months before screening, or the investigator judges that other intraocular surgery other than PPV may be required within 6 months after the start of the study; (5) The study eye has received ophthalmic surgery involving macular area (such as PDT treatment, macular translocation, etc.), except local/grid retinal photocoagulation. 3. System-related exclusion criteria: Subjects with any of the following systemic diseases: (1) Poor blood glucose control within 3 months before screening, (defined as the change of oral hypoglycemic drug treatment to insulin treatment, the start of insulin pump treatment or the doubling of the times of daily insulin injections); (2) Impaired renal function (Crea is 2 times higher than the upper limit of the laboratory normal value of the center) or abnormal liver function (ALT and AST are 2 times higher than the upper limit of the laboratory normal value of the center); (3) Poor blood pressure control (defined as systolic blood pressure is greater than or equal to 150mmHg or diastolic blood pressure is greater than or equal to 95 mmHg after antihypertensive drug treatment); (4) Present systemic infection requiring oral, intramuscular injection or intravenous administration; (5) Severe cardiovascular events such as stroke, transient ischemic attack, myocardial infarction or acute congestive heart failure occurred within 6 months before screening; (6) Abnormal coagulation function (prothrombin time is greater than or equal to upper limit of normal value for 3 seconds, activated partial thromboplastin time is greater than or equal to the upper limit of normal value for 10 seconds); (7) Drugs that are toxic to lens, reti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of vitreous hemorrhage 7days to 30 days post surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| BCVA (Best corrected visual acuity);CMT (Central retinal thickness);Cumulative incidence of VH (vitreous hemorrhage) 1m to 6m post surgery;Incidence of macular edema (ME) within 6 months post surgery;Incidence of IVC within 6 months post surgery;Average number of IVCS within 6 months post surgery; | — |
Countries
China
Contacts
Public ContactHua Yan
Tianjin Medical University General Hospital
Outcome results
None listed