Ruijin Hospital
Shanghai, Shanghai Municipality, 20025, China
NCT Number: NCT02816710
To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment of severe proliferative diabetic retinopathy.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Shanghai, Shanghai Municipality, 20025, China
To assess the clinical effects of preoperative, intraoperative or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in pars plana vitrectomy (PPV) with silicone oil tamponade for severe proliferative diabetic retinopathy (PDR). Methods. These patients were randomly assigned to three groups: Group 1 received an IVC injection 3 to 5 days before surgery; Group 2 received an IVC injection at the end of surgery; and Group 3 received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of PPV. Follow-up examinations were performed for at least six months after surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists.
Time frame: 6 months
Time frame: during the operation time
To evaluate the influence of these three methods to the final duration of surgery. We carefully estimated the time of the vitrectomy from insertion to extraction of the 23-gauge three-port trocars.
Time frame: Time between the insertion and extraction of three 23-gauge vitrectomy ports
The grading criteria for intraoperative bleeding: Grade 1, spontaneous cessation of minor bleeding or bleeding that stopped by transient elevation of perfusion pressure; Grade 2, moderate bleeding requiring endodiathermy or broad blood clots formed far away from the bleeding site; Grade 3, thick blood clots exceeding half of the posterior pole or affecting the operation field.
Time frame: postoperatively, up to 1 week
The grading criteria for postoperative preretinal blood: Grade 1, isolated blood clots within 10 disk area but without covering the posterior pole; Grade 2, broad blood clots exceeding 10 disk area regardless of involvement of the posterior pole; Grade 3, broad blood clots exceeding 10 disk area as well as involving the posterior pole. Maximal extent of preretinal blood within 1 week postoperatively was used for grading the extent of hemorrhage.
Time frame: follow up period, up to an average of 6 months after the operation
To monitor the reabsorption time of preretinal blood.
Time frame: follow up period, up to an average of 6 months after the operation
Recurrent vitreous hemorrhage(VH) was referred to any new episode of VH occurring after one week postoperatively, dividing into early stage (≤ 4 weeks) and late stage (> 4 weeks).
Time frame: during the operation time
The number of times electrocoagulation, which was used to stop bleeding, was carefully counted.
Time frame: follow up period, up to an average of 6 months after the operation
Time frame: follow up period, up to an average of 6 months after the operation
Time frame: follow up period, up to an average of 6 months after the operation
due to recurrent retinal detachment or unclear vitreous hemorrhage
Ruijin Hospital
Other
Different Conbercept Injection Methods in Treatment of Severe Proliferative Diabetic Retinopathy
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