Comparison of Intravitreal Anti-VEGF Versus Combination Therapy in Central Retinal Vein Occlusion

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Intravitreal Bevacizumab and Triamcinolone Acetonide With Intravitreal Bevacizumab Alone in Macular Edema Secondary to Central Retinal Vein Occlusion

Conditions
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Central Retinal Vein Occlusion With Macular Edema

Intervention / Treatment
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* Drug: Group A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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. | Drug: Group A<br>* Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml)<br>|
| Active Comparator: Group B<br>Intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months. | Drug: Group A<br>* Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Change in visual acuity | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Foveal Thickness | change in central foveal thickness | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular edema, central retinal vein occlusion, intravitreal bevacizumab