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IRCT20230103057035N1 IRCT 2023-03-18 Shahid Beheshti University of Medical Sciences Evaluation of the effect of Interferon Alfa-2b in diabetic macular edema Evaluation of the effect of Interferon Alfa-2b in combination with intra-vitreal injection of Bevacizumab in the treatment of diabetic macular edema: a randomized double-blinded clinical trial 2023-01-21 anticipated 49 Complete https://irct.ir/trial/67803 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants by covering the bottle containing medicine Clinical caregiver: keeping the condition of the patient secret before the examination Evaluator of the outcome: keeping the condition of the patient secret before the examination Data analyst: keeping the patient's condition secret until the time of analysis. 2 Diabetic macular edema. Intervention 1: Control group: For this group, in sterile conditions, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed at one-month intervals. In this group, patients will be prescribed placebo (artificial tears) and will be used every 6 hours for 4 months. Intervention 2: Intervention group: For this group, in sterile conditions, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed at one-month intervals. In this group, the interferon α 2b drop (1 MU/Ml) starts immediately after the first injection, and patients use one drop in the affected eye every 6 hours for three months. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals When: After finishing the study To whom: Researchers working in academic and scientific institutions Conditions: For further research Where to obtain: In order to receive the documents, please contact the person in charge of the project (Dr. Mehdi Nouri) (working at Torfeh Hospital) in person or by phone (mobile number 09122000493). How to obtain: After contacting the official (Mahdi Noori), the requested documents will be sent to the requester Comments:
public Mahdi noori
NO.5, Mostajabi Street, Iran Street
Tehran Iran (Islamic Republic of) 1157734361 +98 21 3312 7993 drmahdinoori@gmail.com Shahid Beheshti University of Medical Sciences scientific Mahdi noori
No.5, Mostajabi Street, Iran Street
Tehran Iran (Islamic Republic of) 1157734361 +98 21 3312 7993 drmahdinoori@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diabetic patients over 18 years old Macular edema involving the center. BCVA between 20/400-40/20 Central macular thickness greater than or equal to 300 μm Requires 3 IVB injections in the next 12 weeks Retinal clarity, pupillary dilation for OCT, and necessary cooperation for proper fundus photography 18 years 80 years Both E11. 311 unspecified diabetic retinopathy with macular edema Treatment - Drugs Treatment - Drugs Control group: For this group, in sterile conditions, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed at one-month intervals. In this group, patients will be prescribed placebo (artificial tears) and will be used every 6 hours for 4 months. Intervention group: For this group, in sterile conditions, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed at one-month intervals. In this group, the interferon α 2b drop (1 MU/Ml) starts immediately after the first injection, and patients use one drop in the affected eye every 6 hours for three months. Decrease thickness of the central part of the macula. Timepoint: At the beginning of the study and one month after the third injection of bevacizumab. Method of measurement: Oct device (Optical coherence tomography). Improve visual acuity. Timepoint: Before the study and one month after the third injection of bevacizumab. Method of measurement: Optometry. Shahid Beheshti University of Medical Sciences Approved 2022-09-20 Ethics committee of Shahid Beheshti University of Medical Sciences Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)