Comparative study of the effect of intravitreal injection of bevacizumab versus simultaneous intravitreal injection of bevacizumab and triamcinolone acetonide in patients with retinal venous occlusion

Comparative study of the effect of intravitreal injection of bevacizumab versus simultaneous intravitreal injection of bevacizumab and triamcinolone acetonide

This is a randomized clinical trial study in a parallel design. This study is randomized, phase 2-3 study will be performed on 58 eligible patients. A simple randomization method is used for randomization and participants are assigned to two intervention groups.

This study, which will be conducted in Imam Khomeini hospital of Kermanshah, is a double-blinded one. In this study, patients are aware of the study participation, but the person who injects drugs and the participants are kept blind to the type of medication and their dose. All intravitreal injections in the operating room will be performed after preparing the eye with betadine and anesthesia using 0.5% tetracaine drops and placement of the eyelid speculum and using a G 27 needle from the supratemporal part with a distance of 4 mm from the limbus.

Inclusion criteria: All patients who have had retinal vein occlusion in the last 12 weeks Exclusion criteria: History of any previous treatment, including macular laser or intravitreal injection; Having ocular hypertension; Vision better than 20/40 or central macular thickness less than 250 microns; Any type of neovascularization or with retinal arterial occlusion or symptoms in favor of treatment such as cilioretinal and retinal shunts

In the first intervention group, intravitreal injection of 1.25 mg/0.05 mL bevacizumab (Darou Pakhsh Company) will be performed monthly for six months. In the second intervention group, intravitreal injection of 0.05 cc 1.25 mg bevacizumab (Darou Pakhsh Company) and 2 mg/0.05 ml triamcinolone (Darou Pakhsh Company) will be performed two months apart for six months.

Vision

Simple randomization method. Fifty-four cards will be selected, and numbers from 1-54 will be inserted into the cards. The cards will be placed in an envelope. Two project staff took one card from the envelope each time and randomly will given the picked cards to the participants. Even numbers will be assigned to the intervention group and odd numbers to the control group.

This study will be designed as a single-blind. Although patients will not be aware of the type of injected drug, because IVT injection causes Floaters, this study will be considered a single-blind study and, the project staff who is responsible for injecting the medications will be kept blind to the treatment groups. Medications can only be identified by the serial number on the container. The serials are with the main researcher and will remain confidential until the end of the study. The syringes are also similar, and for the group that will receive the two types of drugs, the drugs are combined in one syringe.

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