Trial Outcomes & Findings for Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy (NCT NCT01854593)
NCT ID: NCT01854593
Last Updated: 2014-07-14
Results Overview
Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
69 participants
Primary outcome timeframe
1 month
Results posted on
2014-07-14
Participant Flow
Participant milestones
| Measure |
Bevacizumab and Vitrectomy
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
Sham injection one day before operation and vitrectomy.
Sham injection: Sham injection one day before vitrectomy
Vitrectomy: vitrectomy of 25 gauge system.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
35
|
|
Overall Study
COMPLETED
|
32
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy
Baseline characteristics by cohort
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16 mg/0.05 ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
* Bevacizumab: 0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
* Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
* Sham injection: Sham injection one day before vitrectomy
* Vitrectomy: vitrectomy of 25 gauge system.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Preoperative best corrected visual acuity
|
1.09 LogMAR
STANDARD_DEVIATION 0.60 • n=5 Participants
|
1.14 LogMAR
STANDARD_DEVIATION 0.58 • n=7 Participants
|
1.11 LogMAR
STANDARD_DEVIATION 0.59 • n=5 Participants
|
|
Intra Ocular Pressure
|
15.3 mm Hg
STANDARD_DEVIATION 2.69 • n=5 Participants
|
14.6 mm Hg
STANDARD_DEVIATION 3.42 • n=7 Participants
|
15.0 mm Hg
STANDARD_DEVIATION 3.11 • n=5 Participants
|
|
Hypertension
Yes
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Hypertension
No
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Hyperlipidemia
Yes
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Hyperlipidemia
No
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
HbA1c
|
8.0 %
STANDARD_DEVIATION 1.7 • n=5 Participants
|
7.6 %
STANDARD_DEVIATION 2.0 • n=7 Participants
|
7.8 %
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Use of anticoagulants
Yes
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Use of anticoagulants
No
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Lens status
phakic
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Lens status
pseudophakic
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Persistent vitreous hemorrhage
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Previous panretinal photocoagulation
None
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Previous panretinal photocoagulation
Incomplete
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
preoperative Iris neovascularization or neovascular glaucoma
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthVitreoretinal reoperation due to recurrent vitreous hemorrhage.
Outcome measures
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy
|
|---|---|---|
|
Reoperation
|
1 participants
|
7 participants
|
SECONDARY outcome
Timeframe: End of the surgery.Calculate the number of coagulators for the intra operative hemorrhage.
Outcome measures
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy
|
|---|---|---|
|
Intra Operative Hemorrhage
|
0.63 coagulators
Standard Deviation 1.0
|
1.3 coagulators
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 1 monthPostoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.
Outcome measures
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy
|
|---|---|---|
|
Postoperative Vitreous Hemorrhage.
|
3 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Start of surgery.Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.
Outcome measures
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy
|
|---|---|---|
|
Vascular Endothelial Growth Factor Concentration in Vitreous
|
25.0 μg/ml
Standard Deviation 13.6
|
1315 μg/ml
Standard Deviation 1153
|
SECONDARY outcome
Timeframe: End of surgery.Number of intraoperative endolaser photocoagulation.
Outcome measures
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy
|
|---|---|---|
|
Endolaser Photocoagulation
|
1260 photocoagulation
Standard Deviation 686
|
1335 photocoagulation
Standard Deviation 663
|
SECONDARY outcome
Timeframe: End of surgery.The number of participants who had intraoperative iatrogenic retinal tears.
Outcome measures
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy
|
|---|---|---|
|
Iatrogenic Retinal Tears
|
5 participants
|
5 participants
|
SECONDARY outcome
Timeframe: End of surgery.Outcome measures
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy
|
|---|---|---|
|
Surgical Time
|
49 minutes
Standard Deviation 20
|
56 minutes
Standard Deviation 27
|
SECONDARY outcome
Timeframe: 1 mouth after surgery.Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis. The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome.
Outcome measures
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy
|
|---|---|---|
|
Postoperative Best Corrected Visual Acuity
|
0.46 LogMAR
Standard Deviation 0.54
|
0.43 LogMAR
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 1 monthBest corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity. The higher values represent a worse outcome.
Outcome measures
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy
|
|---|---|---|
|
Best Corrected Visual Acuity Change
|
-0.63 LogMAR
Standard Deviation 0.61
|
-0.73 LogMAR
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Within 1 month after the surgery.The number of participants with progressive or persistent neovascular glaucoma after surgery.
Outcome measures
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy
|
|---|---|---|
|
Postoperative Neovascular Glaucoma
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Within 1 month after the surgery.The number of participants with elevated intraocular pressure after surgery.
Outcome measures
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy
|
|---|---|---|
|
Elevated Intraocular Pressure
|
2 participants
|
6 participants
|
SECONDARY outcome
Timeframe: End of surgery.The number of participants with gas tamponade at the end of the surgery.
Outcome measures
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy
|
|---|---|---|
|
Gas Tamponade
|
23 participants
|
24 participants
|
SECONDARY outcome
Timeframe: End of surgery.The number of participants with silicon oil tamponade at the end of the surgery.
Outcome measures
| Measure |
Bevacizumab and Vitrectomy
n=32 Participants
0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system.
|
Sham Injection and Vitrectomy
n=34 Participants
Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy
|
|---|---|---|
|
Silicon Oil Tamponade
|
4 participants
|
6 participants
|
Adverse Events
Bevacizumab and Vitrectomy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Injection and Vitrectomy
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. Ayumu Manabe
Department of Ophthalmology, Surugadai Hospital of Nihon University
Phone: +81-3-3293-1711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place