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IRCT20130812014333N185 IRCT 2022-05-25 Kermanshah University of Medical Sciences Comparative study of the effect of intravitreal injection of bevacizumab versus simultaneous intravitreal injection of bevacizumab and triamcinolone acetonide 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 2022-04-14 anticipated 58 Complete https://irct.ir/trial/62684 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2-3 Retinal vascular occlusions. Intervention 1: In the first intervention group, an intravitreal injection of 1.25 mg/0.05 mL bevacizumab (Darou Pakhsh Company) will be performed monthly for six months. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Masoumeh Kariminia
Imam Khomeini Hospital, Naghliyeh Street
Kermanshah Iran (Islamic Republic of) 6718443161 +98 83 3727 9104 masume.kariminia1368@gmail.com Kermanshah University of Medical Sciences scientific Dr. Pejvak Azadi
Imam Khomeini Hospital, Naghliyeh Street
Kermanshah Iran (Islamic Republic of) 6718443161 +98 83 3727 8759 Azadipe@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) All patients who have had retinal vein occlusion in the last 12 weeks based on their history no limit no limit Both 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 Media opacity Any type of neovascularization or with retinal arterial occlusion or symptoms in favor of treatment such as cilioretinal and retinal shunts Any retinal disease H34 Retinal vascular occlusions Treatment - Drugs Treatment - Drugs In the first intervention group, an 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. Timepoint: First, one and six months after the end of the study. Method of measurement: using Snellen eye chart. Kermanshah University of Medical Sciences Approved 2022-02-13 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)