Trial Outcomes & Findings for Comparison of Intravitreal Anti-VEGF Versus Combination Therapy in Central Retinal Vein Occlusion (NCT NCT04812977)

Results Overview

Change in visual acuity

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2022-10-03

Participant Flow

All enrolled participants completed the study.

Participant milestones

Participant milestones
Measure	Group A A single injection of triamcinolone acetonide (Kenacort-AⓇ). (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) was given at the start of the treatment whereas intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months. Group A: Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml)	Group B Intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=15 Participants A single injection of triamcinolone acetonide (Kenacort-AⓇ). (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) was given at the start of the treatment whereas intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months. Group A: Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml)	Group B n=15 Participants Intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months. Group A: Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml)	Total n=30 Participants Total of all reporting groups
Age, Continuous	60.93 years STANDARD_DEVIATION 4.38 • n=15 Participants	60.73 years STANDARD_DEVIATION 3.67 • n=15 Participants	60.83 years STANDARD_DEVIATION 4.03 • n=30 Participants
Sex: Female, Male Female	05 Participants n=15 Participants	08 Participants n=15 Participants	13 Participants n=30 Participants
Sex: Female, Male Male	10 Participants n=15 Participants	07 Participants n=15 Participants	17 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Pakistan	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants
Visual acuity	0.87 logMAR units STANDARD_DEVIATION 0.09 • n=15 Participants	0.88 logMAR units STANDARD_DEVIATION 0.1 • n=15 Participants	0.87 logMAR units STANDARD_DEVIATION 0.09 • n=30 Participants
central foveal thickness	673.67 microns STANDARD_DEVIATION 38.33 • n=15 Participants	674.07 microns STANDARD_DEVIATION 36.32 • n=15 Participants	673.87 microns STANDARD_DEVIATION 37.33 • n=30 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Change in visual acuity

Outcome measures

Outcome measures
Measure	Combination Group n=15 Participants A single injection of triamcinolone acetonide (Kenacort-AⓇ). (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) was given at the start of the treatment whereas intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months	Standard Group n=15 Participants group B received IVB (1.25mg/0.05ml) alone
Visual Acuity	0.32 logMAR units Standard Deviation 0.06	0.44 logMAR units Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline and 6 months

change in central foveal thickness

Outcome measures

Outcome measures
Measure	Combination Group n=15 Participants A single injection of triamcinolone acetonide (Kenacort-AⓇ). (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) was given at the start of the treatment whereas intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months	Standard Group n=15 Participants group B received IVB (1.25mg/0.05ml) alone
Central Foveal Thickness	264.4 microns Standard Deviation 16.73	271.01 microns Standard Deviation 20.14

Adverse Events

Combination Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Group

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

Yousaf Jamal Mahsood

Hayatabad Medical Complex, Peshawar

Phone: 091921714047

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place