Proliferative Diabetic retinopathy
Conditions
Interventions
Preoperative IVC+PPV group (combined group):Intravitreal injection of Conbercept before PPV + PPV
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Willingness to provide written informed consent and to comply with all scheduled follow-up visits as required by the study protocol. 2. Age >= 18 years, regardless of gender. 3. Confirmed diagnosis of type 2 diabetes mellitus. 4. Glycosylated hemoglobin (HbA1c) value <=10%. 5. Presence of fibrovascular membrane(s) in the study eye attributable to Proliferative Diabetic Retinopathy (PDR). 6. 6. Best Corrected Visual Acuity (BCVA) in the study eye, measured using the International Standard Logarithmic Visual Acuity Chart at 4 meters or 1 meter, ranging from light perception to 0.3 logMAR (equivalent to 0.5 in Snellen decimal fraction).
Exclusion criteria
Exclusion criteria: Any one of the exclusion criteria is excluded: 1. Eye-related exclusion criteria: Patients with any of the following eye diseases: (1) Active ocular infection in either eye (such as blepharitis, keratitis, scleritis, conjunctivitis, etc.); (2) In addition to DME, the target eye also suffers from other ophthalmic conditions that cause retino/macular degeneration or visual changes (such as retinal vein occlusion, CNV, macular hole, etc.); (3) Glaucoma in the target eye, or a history of glaucoma filtration surgery; (4) The target eye has no (artificial) lens; (5) The target eye is severely proliferated and not suitable for anti-VEGF therapy; (6) Pathological myopia in the target eye (defined as axial length >= 26.5mm and corneal diopter = 6.00D); (7) The proliferative membrane of the target eye fibers exceeds the equator; (8) Traction retinal detachment involving the periphery of the target eye; (9) The target eye has a foraminal retinal detachment; (10) Presence of iris neovascularization in the target eye; (11) Vitreous volume blood duration of the target eye for more than 3 months. Note: If it is determined that the patient has RVO-ME during the operation, there is no need to withdraw from the group, add a diagnostic explanation after the operation, and continue to follow up according to the protocol; If the patient is found to have an inactive fibrotic resting membrane (dead film) in the fundus during surgery, that is, it is not suitable for anti-VEGF therapy, it will be considered as a violation of the protocol, and the patient will be removed from the group and not included in the full analysis set (FAS), and the reason will be recorded. Those who have any of the following ocular treatment conditions: (1) History of PPV surgery in the target eye before screening; (2) The target eye has received any drug-containing intraocular implant (such as dexamethasone ocular implant) within 6 months prior to screening; (3) The target eye has received anti-VEGF drugs (such as conbercept, ranibizumab, aflibercept, faroximab, etc.) within 2 months before screening; (4) The target eye has undergone any other intraocular surgery (such as cataract surgery, posterior capsulotomy of YAG, 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 target eye has undergone ocular surgery involving the macular area (such as PDT treatment, macular transposition, etc.), except for local/grating retinal photocoagulation. 2. Those with systemic diseases or pregnancy who are not suitable for surgery or anti-VEGF treatment: (1) Those who are not suitable for surgical procedures with unsatisfactory blood glucose control (defined as changing from oral hypoglycemic drug therapy to insulin therapy, starting insulin pump therapy, or doubling the number of daily insulin injections) within 3 months before screening; (2) Impaired kidney function (requiring dialysis or kidney transplantation) or abnormal liver function (ALT and AST are 2 times higher than the upper limit of normal value in our laboratory); (3) Unsatisfactory blood pressure control (defined as systolic blood pressure >=150 mmHg or diastolic blood pressure>=95 mmHg after antihypertensive drug treatment); (4) Systemic infection requiring oral, intramuscular or intravenous administration; (5) Serious cardiovascular events such as stroke, transient ischemic attack, myocardial infarction,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative Hemorrhage Severity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reoperation Rate;CMT (Central retinal thickness);BCVA (Best corrected visual acuity);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