Trial Outcomes & Findings for Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment (NCT NCT00548197)

NCT ID: NCT00548197

Last Updated: 2018-10-16

Results Overview

Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 40 participants
• Primary outcome timeframe: last follow up, an average of 7 months post-operation
• Results posted on: 2018-10-16

Participant Flow

Participant milestones

Measure	Control Group no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy	Intervention Group Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy
Overall Study STARTED	18	22
Overall Study COMPLETED	18	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment

Baseline characteristics by cohort

Measure	Intervention n=22 Participants Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy	Control n=18 Participants no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy	Total n=40 Participants Total of all reporting groups
Age, Continuous	55.8 years STANDARD_DEVIATION 11.3 • n=5 Participants	53.2 years STANDARD_DEVIATION 11.7 • n=7 Participants	54.63 years STANDARD_DEVIATION 11.48 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: last follow up, an average of 7 months post-operation

Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)

Outcome measures

Measure	Intervention n=22 Participants Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy	Control n=18 Participants no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
Best Corrected Visual Acuity	1.1 LogMar Standard Deviation 0.4	1.4 LogMar Standard Deviation 0.3

SECONDARY outcome

Timeframe: Last follow up, an average of 7 months post-operation

Population: Postoperative Vitreous Hemorrhage

Number of Participants with Postoperative Vitreous Hemorrhage

Outcome measures

Measure	Intervention n=22 Participants Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy	Control n=18 Participants no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
Anatomic Status of the Retina	0 Participants	7 Participants

Adverse Events

Intervention

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention n=22 participants at risk Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy	Control n=18 participants at risk no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
Eye disorders Inferior rhegmatogenous retinal detachment and perisillicone proliferations	4.5% 1/22 • Number of events 1	5.6% 1/18 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Mehdi Modarres

Iran university of medical Sciences

Phone: 009888602217

Email: mmodarres51@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place