Trial Outcomes & Findings for Combined Therapy of Posterior Subtenon Triamcinolone Acetonide and Intravitreal Bevacizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion (NCT NCT01614509)

Results Overview

Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

baseline, 1, 3, 6 months after injection

Results posted on

2012-12-04

Participant Flow

Conditions: Macular edema secondary to Branch Retinal Vein Occlusion The recruitment period: from Jan 2012 to Aug 2012

During the follow up period, Not attendants, participants who were received other intraocular surgeries and etc. were excluded.

Participant milestones

Participant milestones
Measure	Monotherapy Group The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.	Combined Group The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
Overall Study STARTED	24	21
Overall Study COMPLETED	23	18
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combined Therapy of Posterior Subtenon Triamcinolone Acetonide and Intravitreal Bevacizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Monotherapy Group n=24 Participants The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.	Combined Group n=21 Participants The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Age Continuous	62.04 years STANDARD_DEVIATION 10.498 • n=5 Participants	60.24 years STANDARD_DEVIATION 14.983 • n=7 Participants	61.20 years STANDARD_DEVIATION 12.668 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment Korea, Republic of	24 participants n=5 Participants	21 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 1, 3, 6 months after injection

Population: Participants who were finished 6 months follow up period.

Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection

Outcome measures

Outcome measures
Measure	Monotherapy Group n=23 Participants The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.	Combined Group n=18 Participants The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
Changes of Central Retinal Thickness at baseline	510.35 micrometer Standard Deviation 185.36	468.22 micrometer Standard Deviation 159.26
Changes of Central Retinal Thickness 1 month after injection	291.48 micrometer Standard Deviation 100.19	233.33 micrometer Standard Deviation 79.95
Changes of Central Retinal Thickness 3 months after injection	265.35 micrometer Standard Deviation 106.85	233.22 micrometer Standard Deviation 57.09
Changes of Central Retinal Thickness 6 months after injection	246.48 micrometer Standard Deviation 88.00	217.83 micrometer Standard Deviation 42.64

SECONDARY outcome

Timeframe: 6 months

Population: We evaluated mean times of additional intravitreal injection because of recurrent macular edema within participants who who were finished 6 months follow up periods.

Comparison of the additional intravitreal bevacizumab injection of intravitreal bevacizumab monotherapy or combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab during 6 months

Outcome measures

Outcome measures
Measure	Monotherapy Group n=23 Participants The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.	Combined Group n=18 Participants The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
Additional Intravitreal Bevacizumab Injection	0.96 times of injection Standard Deviation 0.83	0.44 times of injection Standard Deviation 0.70

Adverse Events

Monotherapy Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combined 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

Dr. Min Sagong

Yeungnam University College of Medicine

Phone: 82-53-620-4191

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place