Trial Outcomes & Findings for Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy (NCT NCT02816710)
NCT ID: NCT02816710
Last Updated: 2019-11-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
112 participants
Primary outcome timeframe
6 months
Results posted on
2019-11-21
Participant Flow
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.
Participant milestones
| Measure |
IVC Preoperative Group
Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
|
IVC Postoperative Group
Patients in this group received an IVC injection at the end of surgery.
|
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).
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
36
|
|
Overall Study
COMPLETED
|
34
|
35
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
IVC Preoperative Group
n=34 Participants
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.
|
IVC Postoperative Group
n=35 Participants
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.
|
IVC Pre- and Post-operative Group
n=29 Participants
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.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.76 years
STANDARD_DEVIATION 13.47 • n=34 Participants
|
53.97 years
STANDARD_DEVIATION 14.76 • n=35 Participants
|
52.55 years
STANDARD_DEVIATION 14.62 • n=29 Participants
|
52.44 years
STANDARD_DEVIATION 14.20 • n=98 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=34 Participants
|
19 Participants
n=35 Participants
|
13 Participants
n=29 Participants
|
52 Participants
n=98 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=34 Participants
|
16 Participants
n=35 Participants
|
16 Participants
n=29 Participants
|
46 Participants
n=98 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Hypertension
|
15 Participants
n=34 Participants
|
17 Participants
n=35 Participants
|
13 Participants
n=29 Participants
|
45 Participants
n=98 Participants
|
|
HbA1c at time of surgery
|
7.12 %
STANDARD_DEVIATION 1.52 • n=34 Participants
|
7.59 %
STANDARD_DEVIATION 1.36 • n=35 Participants
|
7.88 %
STANDARD_DEVIATION 1.26 • n=29 Participants
|
7.51 %
STANDARD_DEVIATION 1.41 • n=98 Participants
|
|
Type 1 diabetes
|
3 Participants
n=34 Participants
|
2 Participants
n=35 Participants
|
3 Participants
n=29 Participants
|
8 Participants
n=98 Participants
|
|
Duration of diabetes (years)
|
14.50 years
STANDARD_DEVIATION 5.16 • n=34 Participants
|
12.86 years
STANDARD_DEVIATION 5.23 • n=35 Participants
|
12.66 years
STANDARD_DEVIATION 5.24 • n=29 Participants
|
13.37 years
STANDARD_DEVIATION 5.22 • n=98 Participants
|
|
Study eye (right eye)
|
21 eyes
n=34 Participants
|
17 eyes
n=35 Participants
|
16 eyes
n=29 Participants
|
54 eyes
n=98 Participants
|
|
Previous history of pan-retinal photocoagulation (PRP)
|
11 Participants
n=34 Participants
|
15 Participants
n=35 Participants
|
13 Participants
n=29 Participants
|
39 Participants
n=98 Participants
|
|
LogMAR Best Corrected Visual Acuity (BCVA)
|
1.95 LogMAR
STANDARD_DEVIATION 0.43 • n=34 Participants
|
1.97 LogMAR
STANDARD_DEVIATION 0.37 • n=35 Participants
|
1.98 LogMAR
STANDARD_DEVIATION 0.44 • n=29 Participants
|
1.96 LogMAR
STANDARD_DEVIATION 0.41 • n=98 Participants
|
|
Lens status (pseudophakic)
|
4 Participants
n=34 Participants
|
3 Participants
n=35 Participants
|
7 Participants
n=29 Participants
|
14 Participants
n=98 Participants
|
|
Preoperative iris neovascularization
|
2 Participants
n=34 Participants
|
3 Participants
n=35 Participants
|
2 Participants
n=29 Participants
|
7 Participants
n=98 Participants
|
|
Extent of vitreoretinal adhesion grade
3
|
9 Participants
n=34 Participants
|
10 Participants
n=35 Participants
|
17 Participants
n=29 Participants
|
36 Participants
n=98 Participants
|
|
Extent of vitreoretinal adhesion grade
2
|
11 Participants
n=34 Participants
|
10 Participants
n=35 Participants
|
8 Participants
n=29 Participants
|
29 Participants
n=98 Participants
|
|
Extent of vitreoretinal adhesion grade
1
|
14 Participants
n=34 Participants
|
15 Participants
n=35 Participants
|
4 Participants
n=29 Participants
|
33 Participants
n=98 Participants
|
|
Extent of vitreoretinal adhesion grade
0
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=98 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
IVC Preoperative Group
n=34 Participants
Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
|
IVC Postoperative Group
n=35 Participants
Patients in this group received an IVC injection at the end of surgery.
|
IVC Pre- and Post-operative Group
n=29 Participants
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.
|
|---|---|---|---|
|
Best-corrected Visual Acuity
|
1.25 LogMAR
Standard Deviation 0.45
|
1.29 LogMAR
Standard Deviation 0.46
|
1.16 LogMAR
Standard Deviation 0.44
|
PRIMARY outcome
Timeframe: during the operation timeTo 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.
Outcome measures
| Measure |
IVC Preoperative Group
n=34 Participants
Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
|
IVC Postoperative Group
n=35 Participants
Patients in this group received an IVC injection at the end of surgery.
|
IVC Pre- and Post-operative Group
n=29 Participants
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.
|
|---|---|---|---|
|
Duration of Surgery
|
55.41 minutes
Standard Deviation 11.24
|
67.66 minutes
Standard Deviation 15.15
|
57.86 minutes
Standard Deviation 13.23
|
PRIMARY outcome
Timeframe: Time between the insertion and extraction of three 23-gauge vitrectomy portsThe 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.
Outcome measures
| Measure |
IVC Preoperative Group
n=34 Participants
Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
|
IVC Postoperative Group
n=35 Participants
Patients in this group received an IVC injection at the end of surgery.
|
IVC Pre- and Post-operative Group
n=29 Participants
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.
|
|---|---|---|---|
|
Intraoperative Bleeding
Grade 2
|
12 Participants
|
16 Participants
|
11 Participants
|
|
Intraoperative Bleeding
Grade 1
|
15 Participants
|
7 Participants
|
12 Participants
|
|
Intraoperative Bleeding
Grade 3
|
7 Participants
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: postoperatively, up to 1 weekThe 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.
Outcome measures
| Measure |
IVC Preoperative Group
n=34 Participants
Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
|
IVC Postoperative Group
n=35 Participants
Patients in this group received an IVC injection at the end of surgery.
|
IVC Pre- and Post-operative Group
n=29 Participants
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.
|
|---|---|---|---|
|
Postoperative Preretinal Blood
Grade 1
|
14 Participants
|
15 Participants
|
17 Participants
|
|
Postoperative Preretinal Blood
Grade 2
|
11 Participants
|
11 Participants
|
8 Participants
|
|
Postoperative Preretinal Blood
Grade 3
|
9 Participants
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: follow up period, up to an average of 6 months after the operationTo monitor the reabsorption time of preretinal blood.
Outcome measures
| Measure |
IVC Preoperative Group
n=34 Participants
Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
|
IVC Postoperative Group
n=35 Participants
Patients in this group received an IVC injection at the end of surgery.
|
IVC Pre- and Post-operative Group
n=29 Participants
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.
|
|---|---|---|---|
|
Reabsorption Time of Blood
|
11.24 days
Standard Deviation 4.33
|
12.23 days
Standard Deviation 6.19
|
10.10 days
Standard Deviation 4.07
|
SECONDARY outcome
Timeframe: follow up period, up to an average of 6 months after the operationRecurrent 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).
Outcome measures
| Measure |
IVC Preoperative Group
n=34 Participants
Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
|
IVC Postoperative Group
n=35 Participants
Patients in this group received an IVC injection at the end of surgery.
|
IVC Pre- and Post-operative Group
n=29 Participants
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.
|
|---|---|---|---|
|
Recurrent Vitreous Hemorrhage
early vitreous hemorrhage
|
6 Participants
|
7 Participants
|
2 Participants
|
|
Recurrent Vitreous Hemorrhage
late vitreous hemorrhage
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Recurrent Vitreous Hemorrhage
no vitreous hemorrhge
|
23 Participants
|
25 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: during the operation timeThe number of times electrocoagulation, which was used to stop bleeding, was carefully counted.
Outcome measures
| Measure |
IVC Preoperative Group
n=34 Participants
Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
|
IVC Postoperative Group
n=35 Participants
Patients in this group received an IVC injection at the end of surgery.
|
IVC Pre- and Post-operative Group
n=29 Participants
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.
|
|---|---|---|---|
|
Frequency of Intraoperative Electrocoagulation
|
1.73 events
Standard Deviation 1.26
|
3.00 events
Standard Deviation 1.14
|
1.34 events
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: follow up period, up to an average of 6 months after the operationOutcome measures
| Measure |
IVC Preoperative Group
n=34 Participants
Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
|
IVC Postoperative Group
n=35 Participants
Patients in this group received an IVC injection at the end of surgery.
|
IVC Pre- and Post-operative Group
n=29 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Neovascular Glaucoma (NVG)
|
4 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: follow up period, up to an average of 6 months after the operationOutcome measures
| Measure |
IVC Preoperative Group
n=34 Participants
Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
|
IVC Postoperative Group
n=35 Participants
Patients in this group received an IVC injection at the end of surgery.
|
IVC Pre- and Post-operative Group
n=29 Participants
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.
|
|---|---|---|---|
|
Recurrent Retinal Detachment
|
4 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: follow up period, up to an average of 6 months after the operationdue to recurrent retinal detachment or unclear vitreous hemorrhage
Outcome measures
| Measure |
IVC Preoperative Group
n=34 Participants
Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
|
IVC Postoperative Group
n=35 Participants
Patients in this group received an IVC injection at the end of surgery.
|
IVC Pre- and Post-operative Group
n=29 Participants
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.
|
|---|---|---|---|
|
Need for Reoperation
|
11 Participants
|
9 Participants
|
6 Participants
|
Adverse Events
IVC Preoperative Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IVC Postoperative Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IVC Pre- and Post-operative Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Xi Shen
Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, 197 Ruijin Er Road, 200025, Shanghai, China.
Phone: 021-64370025
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place