Clinical trial NCT04812977
Conditions: Central Retinal Vein Occlusion With Macular Edema
Keywords: central retinal vein occlusion macular edema intravitreal bevacizumab
Sponsor: Hayatabad Medical Complex
Start date: 2018-06-10; Completion date: 2018-12-10
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

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.

Detailed description:

Arms: arm 1: 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. arm 2: Intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months.
Interventions: intervention 1: Group A
Intervention descriptions: intervention 1: Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml)

Protocol documents:
Prot_SAP_000.pdf: 
COMPARISON OF INTRAVITREAL BEVACIZUMAB AND 
TRIAMCINOLONE ACETONIDE WITH INTRAVITREAL BEVACIZUMAB 
ALONE IN MACULAR EDEMA SECONDARY TO CENTRAL RETINAL 
VEIN OCCLUSION 
 
 
ClinicalTrials.gov Identifier: NCT04812977 
 
Date: June 7, 2018 
 


 
 
METHODS  
 
The study was approved by the ethical review committee of Hayatabad Medical Complex, 
Peshawar, Pakistan and adhered to the tenets of the declaration of Helsinki (Ref. no. 
094/HEC/PICO/18). It was a quasi-experimental study conducted at the Department of 
Ophthalmology, Hayatabad Medical Complex (HMC), Peshawar from June 2018 to December 
2018. This trial was registered with https://clinicaltrials.gov (ClinicalTrials.gov Identifier: 
NCT04812977). The sample size for this study was calculated by a two-sample comparison of 
percentages calculator in which post-injection percentages were used. The SCORE study had 
shown that 3-line visual acuity gain was 30 percent from the baseline while another study 
conducted in India had shown that 3-line gain of visual acuity in 85 percent of patient15. For a 
2-sided confidence level of 95% and power of 80%, the total sample size of 30 subjects with 
15 in each group was calculated by using an online calculator. The subjects were recruited from 
the out-patient department (OPD). The written informed consent was taken from all subjects. 
Non-random sampling technique was used. Subjects were assigned to the treatment groups 
based on their presentation sequence; odd numbers were sent to group A and even numbers to 
group B. The CONSORT 2010 flow diagram is shown in figure 1. Subjects of either gender, 
age greater than or equal to 40 years, having ME 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 
by consultant vitreo-retina were included in this study. Subjects excluded from the study were 
those who 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. The slit lamp 
biomicroscopic examination was performed and clinically diagnosis of the presence of ME due 
to CRVO were documented. For each subject baseline (BCVA) was recorded on the Log MAR 
visual acuity chart. Base-line SD-OCT was done to record central foveal thickness (CFT).  
Combination Therapy  
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 
received combination therapy of IVB (1.25mg/0.05ml) and IVT (2mg/0.05ml) injection while 
group B received IVB (1.25mg/0.05ml) alone. All subjects were observed by a vitreo-retina 
consultant. The main outcome of the study was an improvement in visual acuity and central 
foveal thickness CFT on SD-OCT from baseline to the sixth month. At each subsequent visit 
at 3, 6 months post-injection, patient visual acuity (VA in Log-MAR), and central foveal 
thickness (on SD-OCT) were measured.  
Statistical Analysis:  
The data were analyzed by using SPSS version 24. The post-injection visual acuity and central 
foveal thickness were used to calculate results and student t-test were applied on these two 
variables of group A and group B. The with-in the groups and between the groups' comparisons 
were done to check for any statistical difference between the outcome at baseline and follow-
up. A p-value of < 0.05 was taken as significant.