Trial Outcomes & Findings for Eye Injections of Bevacizumab for Lowering Risk of Scar Tissue in the Retina and Repeated Retinal Detachment. (NCT NCT01860586)

Last Updated: 2017-04-17

Results Overview

This will be assessed by the frequency (occurences) of retinal detachments in patients that have intravitreal bevacizumab injections versus prior patients that did not have intravitreal bevacizumab injections.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

up to 6 months

Results posted on

2017-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	Bevacizumab Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections) Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Eye Injections of Bevacizumab for Lowering Risk of Scar Tissue in the Retina and Repeated Retinal Detachment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab n=20 Participants Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections) Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3.
Age, Continuous	59 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 months

Population: Bevacizumab treated patients with recurrent retinal detachment

Outcome measures

Outcome measures
Measure	Bevacizumab n=20 Participants Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections) Bevacizumab: .005 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3.
The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease)	6 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Number of patients treated with bevacizumab who developed epiretinal membrane

To determine if intravitreal bevacizumab injections will increase or decrease the occurences (cases) of epiretinal membranes .

Outcome measures

Outcome measures
Measure	Bevacizumab n=20 Participants Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections) Bevacizumab: .005 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3.
The Effect of Intravitreal Bevacizumab Injections on the Development of Epiretinal Membranes (Increase or Decrease)	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Final logMAR visual acuity of patients treated with bevacizumab

Increase or decrease in amount of letters read after intravitreal bevacizumab injections versus control patient that did not receive injections of intravitreal bevacizumab.

Outcome measures

Outcome measures
Measure	Bevacizumab n=20 Participants Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections) Bevacizumab: .005 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3.
Intravitreal Bevacizumab Injections Impact on Visual Acuity Score (Change in Letters Read).	1.43 logMAR visual acuity Standard Deviation 0.70

Adverse Events

Bevacizumab

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. Jason Hsu, Principal Investigator

Mid-Atlantic Retina

Phone: 215-928-3092

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place