Trial Outcomes & Findings for Evaluation of the Effect of Intravitreal Injections of Anti-VEGF on Macular Perfusion in Diabetic Patients Using OCTA (NCT NCT03246152)

Last Updated: 2020-01-30

Results Overview

Effect of repeated intravitreal Anti-VEGF injections on Foveal Avascular Zone (FAZ) area measured using the freehand tool of ImageJ

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

31 participants

Primary outcome timeframe

At baseline and after 3-6 consecutive monthly injections.

Results posted on

2020-01-30

Participant Flow

This is the number of enrolled patients that completed the study.

Participant milestones

Participant milestones
Measure	Bevacizumab Group Monthly intravitreal injection of Bevacizumab for at least 3 consecutive months. This is followed by treat and extend regimen after resolution of macular edema. Bevacizumab: Repeated intravitreal injections of Bevacizumab monthly
Overall Study STARTED	31
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Bevacizumab Group Monthly intravitreal injection of Bevacizumab for at least 3 consecutive months. This is followed by treat and extend regimen after resolution of macular edema. Bevacizumab: Repeated intravitreal injections of Bevacizumab monthly
Overall Study Lost to Follow-up	2
Overall Study Protocol Violation	1

Baseline Characteristics

Evaluation of the Effect of Intravitreal Injections of Anti-VEGF on Macular Perfusion in Diabetic Patients Using OCTA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab Group n=31 Participants Monthly intravitreal injection of Bevacizumab for at least 3 consecutive months. This is followed by treat and extend regimen after resolution of macular edema. Bevacizumab: Repeated intravitreal injections of Bevacizumab monthly
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	54.8 Years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	14 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	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	31 Participants n=5 Participants
Region of Enrollment Egypt	31 participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline and after 3-6 consecutive monthly injections.

Population: Patients with adequate image quality

Effect of repeated intravitreal Anti-VEGF injections on Foveal Avascular Zone (FAZ) area measured using the freehand tool of ImageJ

Outcome measures

Outcome measures
Measure	Bevacizumab Group n=26 Participants Monthly intravitreal injection of Bevacizumab for at least 3 consecutive months. This is followed by treat and extend regimen after resolution of macular edema. Bevacizumab: Repeated intravitreal injections of Bevacizumab monthly
FAZ Area Change	0.03 mm^2 Standard Deviation 0.1

PRIMARY outcome

Timeframe: At baseline and after 3-6 consecutive monthly injections.

Population: Patients with adequate image quality

Effect of repeated intravitreal Anti-VEGF injections on macular capillary density using the change in the skeletonized vascular density and fractal dimension measured by ImageJ

Outcome measures

Outcome measures
Measure	Bevacizumab Group n=26 Participants Monthly intravitreal injection of Bevacizumab for at least 3 consecutive months. This is followed by treat and extend regimen after resolution of macular edema. Bevacizumab: Repeated intravitreal injections of Bevacizumab monthly
Macular Capillary Density Change at Full Retinal Thickness	-2.5 percentage of vascularity Standard Deviation 5.72

SECONDARY outcome

Timeframe: At baseline and after 3-6 consecutive monthly injections.

Population: Patients with good image quality

Correlation of BCVA change with degree of capillary non-perfusion before and after injections

Outcome measures

Outcome measures
Measure	Bevacizumab Group n=26 Participants Monthly intravitreal injection of Bevacizumab for at least 3 consecutive months. This is followed by treat and extend regimen after resolution of macular edema. Bevacizumab: Repeated intravitreal injections of Bevacizumab monthly
BCVA Change	-0.21 Logmar Standard Deviation 0.27

Adverse Events

Bevacizumab Group

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bevacizumab Group n=31 participants at risk Monthly intravitreal injection of Bevacizumab for at least 3 consecutive months. This is followed by treat and extend regimen after resolution of macular edema. Bevacizumab: Repeated intravitreal injections of Bevacizumab monthly
Eye disorders Subconjunctival hemorrhage	41.9% 13/31 • 3 months
Eye disorders Ocular irritation	16.1% 5/31 • 3 months

Additional Information

Dr. Ayman Elnahry

Cairo University

Phone: 00201224927604

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place