Central Retinal Vein Occlusion With Macular Edema
Conditions
Keywords
central retinal vein occlusion, macular edema, intravitreal bevacizumab
Brief summary
To compare the effect of intravitreal-Bevacizumab and Triamcinolone with intravitreal-Bevacizumab alone on visual acuity and central foveal thickness in patients with macular edema secondary to central retinal vein occlusion.
Interventions
DRUGGroup A
Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml)
Sponsors
Hayatabad Medical Complex
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects of either gender, age 40-80 years, having macular edema secondary to CRVO, Best-corrected visual acuity (BCVA) of less than or equal to 0.3 on Log MAR chart (Snellen equivalent of 6/12), Central foveal thickness CFT greater than or equal to 250 microns on Heidelberg Spectralis Spectral Domain Optical coherence tomography (SD-OCT) and clinical diagnosis of CRVO.
Exclusion criteria
* previously received laser treatment and/or intravitreal injection of any Anti-VEGF agent, having one eye, diagnosed case of glaucoma, family history of glaucoma, young patient, and anyone who has received any treatment for CRVO before presenting to us.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | Baseline and 6 months | Change in visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Foveal Thickness | Baseline and 6 months | change in central foveal thickness |
Countries
Pakistan
Participant flow
Pre-assignment details
All enrolled participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 15 |
| Group B 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) | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Group A | Group B | Total |
|---|---|---|---|
| Age, Continuous | 60.93 years STANDARD_DEVIATION 4.38 | 60.73 years STANDARD_DEVIATION 3.67 | 60.83 years STANDARD_DEVIATION 4.03 |
| central foveal thickness | 673.67 microns STANDARD_DEVIATION 38.33 | 674.07 microns STANDARD_DEVIATION 36.32 | 673.87 microns STANDARD_DEVIATION 37.33 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Pakistan | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Female | 05 Participants | 08 Participants | 13 Participants |
| Sex: Female, Male Male | 10 Participants | 07 Participants | 17 Participants |
| Visual acuity | 0.87 logMAR units STANDARD_DEVIATION 0.09 | 0.88 logMAR units STANDARD_DEVIATION 0.1 | 0.87 logMAR units STANDARD_DEVIATION 0.09 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Visual Acuity
Change in visual acuity
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Group | Visual Acuity | 0.32 logMAR units | Standard Deviation 0.06 |
| Standard Group | Visual Acuity | 0.44 logMAR units | Standard Deviation 0.06 |
Secondary
Central Foveal Thickness
change in central foveal thickness
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Group | Central Foveal Thickness | 264.4 microns | Standard Deviation 16.73 |
| Standard Group | Central Foveal Thickness | 271.01 microns | Standard Deviation 20.14 |