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To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment of severe proliferative diabetic retinopathy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVC Preoperative group | Experimental | Conbercept injection before vitrectomy |
|
| IVC Postoperative group | Experimental | Conbercept injection at the end of vitrectomy |
|
| IVC Pre- and Post-operative group | Experimental | First conbercept injection before vitrectomy and second at the end of operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conbercept | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Best-corrected Visual Acuity | 6 months | |
| Duration of Surgery | 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. | during the operation time |
| Intraoperative Bleeding | 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 between the insertion and extraction of three 23-gauge vitrectomy ports |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Preretinal Blood | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xi Shen, PhD | Shanghai Jiao Tong University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Shanghai | Shanghai Municipality | 20025 | China |
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The study was performed in the department of Ophthalmology, Ruijin Hospital, affiliated with Shanghai Jiaotong University School of Medicine, between July 2016 and September 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | IVC Preoperative Group | Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery. |
| FG001 | IVC Postoperative Group | Patients in this group received an IVC injection at the end of surgery. |
| FG002 | IVC Pre- and Post-operative Group | Patients in this group received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of pars plana vitrectomy (PPV). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IVC Preoperative Group | Conbercept injection before vitrectomy Conbercept: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Best-corrected Visual Acuity | Posted | Mean | Standard Deviation | LogMAR | 6 months |
|
6 months
Systemic adverse events such as heart failure, myocardial infarction or acute cerebrovascular diseases and ocular adverse events like endophthalmitis or ocular toxicity were observed in all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVC Preoperative Group | Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Xi Shen | Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, 197 Ruijin Er Road, 200025, Shanghai, China. | 021-64370025 | carl_shen2005@126.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2016 | Aug 19, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2016 | Aug 19, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C527363 | KH902 fusion protein |
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|
| postoperatively, up to 1 week |
| Reabsorption Time of Blood | To monitor the reabsorption time of preretinal blood. | follow up period, up to an average of 6 months after the operation |
| Recurrent Vitreous Hemorrhage | 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). | follow up period, up to an average of 6 months after the operation |
| Frequency of Intraoperative Electrocoagulation | The number of times electrocoagulation, which was used to stop bleeding, was carefully counted. | during the operation time |
| Number of Participants With Neovascular Glaucoma (NVG) | follow up period, up to an average of 6 months after the operation |
| Recurrent Retinal Detachment | follow up period, up to an average of 6 months after the operation |
| Need for Reoperation | due to recurrent retinal detachment or unclear vitreous hemorrhage | follow up period, up to an average of 6 months after the operation |
| BG001 | IVC Postoperative Group | Conbercept injection at the end of vitrectomy Conbercept: 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. |
| BG002 | IVC Pre- and Post-operative Group | First conbercept injection before vitrectomy and second at the end of operation. Conbercept: 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants | No |
|
| HbA1c at time of surgery | Mean | Standard Deviation | % |
|
| Type 1 diabetes | Count of Participants | Participants |
|
| Duration of diabetes (years) | Mean | Standard Deviation | years |
|
| Study eye (right eye) | Number | eyes |
|
| Previous history of pan-retinal photocoagulation (PRP) | Count of Participants | Participants |
|
| LogMAR Best Corrected Visual Acuity (BCVA) | Mean | Standard Deviation | LogMAR |
|
| Lens status (pseudophakic) | Count of Participants | Participants |
|
| Preoperative iris neovascularization | Count of Participants | Participants |
|
| Extent of vitreoretinal adhesion grade | The extent of vitreoretinal adhesion was assessed based on a previous grading system: Grade 0, without any adhesion; Grade 1, focal adhesion in less than 3 sites; Grade 2, broad adhesion in more than 1 site or adhesion at the disc, macular, or vascular arcade; Grade 3, vitreoretinal adhesion extending to the periphery. Grade 3 is considered to be the worst outcome. | Count of Participants | Participants |
|
|
|
| Primary | Duration of Surgery | 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. | Posted | Mean | Standard Deviation | minutes | during the operation time |
|
|
|
| Primary | Intraoperative Bleeding | 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. | Posted | Count of Participants | Participants | Time between the insertion and extraction of three 23-gauge vitrectomy ports |
|
|
|
| Secondary | Postoperative Preretinal Blood | 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. | Posted | Count of Participants | Participants | postoperatively, up to 1 week |
|
|
|
| Secondary | Reabsorption Time of Blood | To monitor the reabsorption time of preretinal blood. | Posted | Mean | Standard Deviation | days | follow up period, up to an average of 6 months after the operation |
|
|
|
| Secondary | Recurrent Vitreous Hemorrhage | 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). | Posted | Count of Participants | Participants | follow up period, up to an average of 6 months after the operation |
|
|
|
| Secondary | Frequency of Intraoperative Electrocoagulation | The number of times electrocoagulation, which was used to stop bleeding, was carefully counted. | Posted | Mean | Standard Deviation | events | during the operation time |
|
|
|
| Secondary | Number of Participants With Neovascular Glaucoma (NVG) | Posted | Count of Participants | Participants | follow up period, up to an average of 6 months after the operation |
|
|
|
| Secondary | Recurrent Retinal Detachment | Posted | Count of Participants | Participants | follow up period, up to an average of 6 months after the operation |
|
|
|
| Secondary | Need for Reoperation | due to recurrent retinal detachment or unclear vitreous hemorrhage | Posted | Count of Participants | Participants | follow up period, up to an average of 6 months after the operation |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | IVC Postoperative Group | Patients in this group received an IVC injection at the end of surgery. | 0 | 35 | 0 | 35 | 0 | 35 |
| EG002 | IVC Pre- and Post-operative Group | Patients in this group received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of PPV. | 0 | 29 | 0 | 29 | 0 | 29 |
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| Male |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Grade 3 |
|
| Title | Measurements |
|---|---|
|
| Grade 3 |
|
| no vitreous hemorrhge |
|