Trial Outcomes & Findings for Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy (NCT NCT00745498)

Results Overview

Recurrent VH was defined as a new episode of grade 1 or more VH occurring more than 1 week after surgery. "Early recurrent VH" was VH occurring \<= 4 weeks and "late recurrent VH" was VH occurring \>4 weeks after surgery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

126 participants

Primary outcome timeframe

6 months

Results posted on

2015-12-21

Participant Flow

Consecutive diabetic patients requiring pars plana vitrectomy (PPV) for complications of diabetic retinopathy at Seoul National University Bundang Hospital were referred to assess eligibility.

If indications for PPV included proliferative diabetic retinopathy (PDR) related complications such as nonclearing vitreous hemorrhage (VH), macula-involving or -threatening tractional retinal detachment (TRD) or fibrovascular proliferation with vitreoretinal adhesions, the patient was enrolled in the study.

Participant milestones

Participant milestones
Measure	Preop IVB Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy	Introp IVB Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy	No IVB Patients will not receive bevacizumab before nor during vitrectomy
Overall Study STARTED	41	43	42
Overall Study COMPLETED	36	37	34
Overall Study NOT COMPLETED	5	6	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Preop IVB Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy	Introp IVB Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy	No IVB Patients will not receive bevacizumab before nor during vitrectomy
Overall Study Lost to Follow-up	1	1	3
Overall Study Injection of intravitreal silicone oil o	3	4	4
Overall Study Non-PDR related VH	0	1	1
Overall Study Edophthalmitis after preoperative IVB	1	0	0

Baseline Characteristics

Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preop IVB n=41 Participants Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy	Intraop IVB n=43 Participants Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy	No IVB n=42 Participants Patients will not receive bevacizumab before nor during vitrectomy	Total n=126 Participants Total of all reporting groups
Age, Continuous	51.0 years STANDARD_DEVIATION 9.5 • n=5 Participants	55.6 years STANDARD_DEVIATION 10.3 • n=7 Participants	55.0 years STANDARD_DEVIATION 11.4 • n=5 Participants	53.9 years STANDARD_DEVIATION 10.5 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	20 Participants n=7 Participants	22 Participants n=5 Participants	57 Participants n=4 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	23 Participants n=7 Participants	20 Participants n=5 Participants	69 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Population: With study power of 80%, significance level of 0.05, assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated. The ITT approach was used for analysis.

Recurrent VH was defined as a new episode of grade 1 or more VH occurring more than 1 week after surgery. "Early recurrent VH" was VH occurring \<= 4 weeks and "late recurrent VH" was VH occurring \>4 weeks after surgery.

Outcome measures

Outcome measures
Measure	Preop IVB n=36 Participants Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy	Intraop IVB n=37 Participants Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy	No IVB n=34 Participants Patients will not receive bevacizumab before nor during vitrectomy
Recurrent VH Incidence (Early and Late) Early	22.2 Percentage of participants	10.8 Percentage of participants	32.4 Percentage of participants
Recurrent VH Incidence (Early and Late) Late	11.1 Percentage of participants	16.2 Percentage of participants	14.7 Percentage of participants

SECONDARY outcome

Timeframe: 6 months

The interval in number of days for VH of grade 1 or more observed at postoperative day 1 to clear-up completely. VH of grade 1 was defined as mild vitreous hemorrhage with visible fundus details, but difficult to evaluate the retinal nerve fiber layer or small vessels.

Outcome measures

Outcome measures
Measure	Preop IVB n=36 Participants Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy	Intraop IVB n=37 Participants Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy	No IVB n=34 Participants Patients will not receive bevacizumab before nor during vitrectomy
Initial Time of Vitreous Clearing (ITVC)	26.4 days Standard Deviation 42.5	10.3 days Standard Deviation 8.2	25.2 days Standard Deviation 26.1

SECONDARY outcome

Timeframe: 6 months

Best-corrected visual acuity (BCVA) at postoperative 6 months

Outcome measures

Outcome measures
Measure	Preop IVB n=36 Participants Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy	Intraop IVB n=37 Participants Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy	No IVB n=34 Participants Patients will not receive bevacizumab before nor during vitrectomy
Visual Outcome	0.62 logMAR Standard Deviation 0.58	0.68 logMAR Standard Deviation 0.47	0.51 logMAR Standard Deviation 0.56

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

Adverse Events

Preop IVB

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Intraop IVB

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

No IVB

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Preop IVB n=41 participants at risk Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy	Intraop IVB n=43 participants at risk Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy	No IVB n=42 participants at risk Patients will not receive bevacizumab before nor during vitrectomy
Eye disorders Rhegmatogenous retinal detachment immediately following operation	0.00% 0/41	0.00% 0/43	2.4% 1/42 • Number of events 1

Other adverse events

Other adverse events
Measure	Preop IVB n=41 participants at risk Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy	Intraop IVB n=43 participants at risk Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy	No IVB n=42 participants at risk Patients will not receive bevacizumab before nor during vitrectomy
Eye disorders neovascular glaucoma following surgery	2.4% 1/41 • Number of events 1	7.0% 3/43 • Number of events 3	2.4% 1/42 • Number of events 1

Additional Information

Dr. Se Joon Woo

Seoul National University Bundang Hospital Department of Ophthalmology

Phone: +82-31-787-7377

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place