Branch Retinal Vein Occlusion
Conditions
Keywords
branch retinal vein occlusion, bevacizumab, triamcinolone acetonide
Brief summary
This study compares the efficacy of intravitreal bevacizumab monotherapy only or combined therapy of posterior subtenon's triamcinolone acetonide and intravitreal bevacizumab for the treatment of macular edema associated with branch retinal vein occlusion.
Interventions
PROCEDUREintravitreal bevacizumab monotherapy
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.
PROCEDUREcombined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab injection
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.
Sponsors
Yeungnam University College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The participant must have macular edema associated branch retinal vein occlusion. 2. The participant has retinal photographs, optical coherence tomography (OCT) and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice. 3. The participant must be willing and able to comply with the protocol.
Exclusion criteria
1. The participant has BRVO with other ocular vascular diseases such as central retinal vein occlusion, hypertensive retinopathy, etc. 2. The participant has any additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy. 3. The participant has a history of treatment for BRVO in the study eye with focal laser photocoagulation, intravitreal triamcinolone acetonide injection or intravitreal Bevacizumab injection 4. The participant has a history of intraocular surgery (including lens replacement surgery). 5. The participant has a history of ocular trauma, or current ocular or periocular infection (including any history of ocular herpes zoster or simplex).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Central Retinal Thickness | baseline, 1, 3, 6 months after injection | Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional Intravitreal Bevacizumab Injection | 6 months | 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 |
Countries
South Korea
Participant flow
Recruitment details
Conditions: Macular edema secondary to Branch Retinal Vein Occlusion The recruitment period: from Jan 2012 to Aug 2012
Pre-assignment details
During the follow up period, Not attendants, participants who were received other intraocular surgeries and etc. were excluded.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 21 |
| Total | 45 |
Baseline characteristics
| Characteristic | Combined Group | Monotherapy Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 10 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 14 Participants | 28 Participants |
| Age Continuous | 60.24 years STANDARD_DEVIATION 14.983 | 62.04 years STANDARD_DEVIATION 10.498 | 61.20 years STANDARD_DEVIATION 12.668 |
| Region of Enrollment Korea, Republic of | 21 participants | 24 participants | 45 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 11 Participants | 14 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 21 |
| serious Total, serious adverse events | 0 / 24 | 0 / 21 |
Outcome results
Primary
Changes of Central Retinal Thickness
Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection
Time frame: baseline, 1, 3, 6 months after injection
Population: Participants who were finished 6 months follow up period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monotherapy Group | Changes of Central Retinal Thickness | at baseline | 510.35 micrometer | Standard Deviation 185.36 |
| Monotherapy Group | Changes of Central Retinal Thickness | 1 month after injection | 291.48 micrometer | Standard Deviation 100.19 |
| Monotherapy Group | Changes of Central Retinal Thickness | 3 months after injection | 265.35 micrometer | Standard Deviation 106.85 |
| Monotherapy Group | Changes of Central Retinal Thickness | 6 months after injection | 246.48 micrometer | Standard Deviation 88 |
| Combined Group | Changes of Central Retinal Thickness | 6 months after injection | 217.83 micrometer | Standard Deviation 42.64 |
| Combined Group | Changes of Central Retinal Thickness | at baseline | 468.22 micrometer | Standard Deviation 159.26 |
| Combined Group | Changes of Central Retinal Thickness | 3 months after injection | 233.22 micrometer | Standard Deviation 57.09 |
| Combined Group | Changes of Central Retinal Thickness | 1 month after injection | 233.33 micrometer | Standard Deviation 79.95 |
Comparison: Central retinal thickness was measured using an optical coherence tomography by every visit. And we compare the difference of central retinal thickness between two groupsp-value: 0.6Wilcoxon (Mann-Whitney)
Secondary
Additional Intravitreal Bevacizumab Injection
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monotherapy Group | Additional Intravitreal Bevacizumab Injection | 0.96 times of injection | Standard Deviation 0.83 |
| Combined Group | Additional Intravitreal Bevacizumab Injection | 0.44 times of injection | Standard Deviation 0.7 |