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IRCT20211130053229N1 IRCT 2023-03-05 Kerman University of Medical Sciences Comparison of the effect of intravitreal injection of bevacizumab (Stevenet) alone with intravitreal injection of bevacizumab and triamcinolone in the treatment of diabetic macular edema with a thickness greater than 500 microns in patients Comparison of the effect of intravitreal injection of Bevacizumab (Stevenet) alone with intravitreal injection of Bevacizumab and Triamcinolone in the treatment of diabetic macular edema with a thickness greater than 500 microns in patients referred to Shafa Hospital. 2023-03-06 anticipated 70 Complete https://irct.ir/trial/60326 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of eyes will be done by block randomization method and with the help of STATA software, Blinding description: The patient and the surgeon will not know the type of injected drug and the drug will be drawn by the operating room personnel. 1-2 Diabetic macular edema. Intervention 1: Intervention group: In the first intervention group, bevacizumab 0.05 ml (1.25 mg) 3 doses will be randomly injected monthly (Avastin; Genen-tech, Inc., South San Francisco, CA (made for F. Hoffmann) -La Roche, Ltd., Basel, Switzerland)-off label drug), in both groups, the injection is done in one eye (the eye with a macular thickness of more than 500 microns). All injections will be performed by a surgeon. The injection is performed after local anesthesia with the help of a 29-gauge needle. Randomization of the eyes is done by the block randomization method and with the help of STATA software. The patient and the surgeon are not aware of the type of injected drug and the drug will be drawn by the prestel in the operating room. (double blinded) All patients will be examined on the 1st and 7th day after the procedure for interior chamber reaction and intraocular pressure measurement. Full ophthalmological examination and OCT will be done again in 4, 8 and 12 weeks. Intervention 2: Intervention group: In the second intervention group, intravitreal triamcinolone acetonide 0.025 ml (1 mg) ((Holzkirchen, Germany) - off label drug) will be added to the first IVB injection with a separate syringe. In both groups, the injection is done in one eye (the eye with macular thickness above 500 microns). All injections will be performed by a surgeon. The injection is performed after local anesthesia with the help of a 29-gauge needle. Randomization of the eyes is done by the block randomization method and with the help of STATA software. The patient and the surgeon are not aware of the type of injected drug and the drug will be drawn by the prestel in the operating room. (double blinded) All patients will be examined on the 1st and 7th day after the procedure for interior chamber reaction and intraocular pressure measurement. Full ophthalmological examination and OCT will be done again in 4, 8 and 12 weeks. Yes - There is a plan to make this available What will be shared: The data obtained in the study can be shared after making the participants unrecognizable. When: After publishing the results, it will be possible to access the data. To whom: The data will be available to medical researchers. Conditions: The use of data is unrestricted if it is not subject to plagiarism. Where to obtain: researchers can ask Dr. Meysam Shokfteh to receive the data. How to obtain: The esteemed applicant must inform the above mentioned researcher of his / her details andthe reason for the need for the data. After consulting with other researchers, He will announce hisagreement or disagreement. Comments:
public Kerman University of Medical Sciences
East Kosar Boulevard, Kosar Square, Shafa Hospital
Kerman Iran (Islamic Republic of) 7618751151 +98 34 3211 5780 maysam.shekofteh@yahoo.com Kerman University of Medical Sciences scientific Meysam Shekofteh
East Kosar Boulevard, Kosar Square, Shafa Hospital
Kerman Iran (Islamic Republic of) 7618751151 +98 34 3211 5780 maysam.shekofteh@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Patients with clinically significant DME according to ETDRS criteria Patients with clinically significant DME based on criteria of central thickness greater than 500 microns no limit no limit Both History of previous DME treatment (focal or panretinal laser coagulation or IVB or IVT) Eye surgery Glaucoma or ocular hypertension monocular vision pregnancy Significant media opacity CMT<500 The patient's absence in follow-up in the following weeks E08.311 Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema Treatment - Drugs Treatment - Drugs Intervention group: In the first intervention group, bevacizumab 0.05 ml (1.25 mg) 3 doses will be randomly injected monthly (Avastin; Genen-tech, Inc., South San Francisco, CA (made for F. Hoffmann) -La Roche, Ltd., Basel, Switzerland)-off label drug), in both groups, the injection is done in one eye (the eye with a macular thickness of more than 500 microns). All injections will be performed by a surgeon. The injection is performed after local anesthesia with the help of a 29-gauge needle. Randomization of the eyes is done by the block randomization method and with the help of STATA software. The patient and the surgeon are not aware of the type of injected drug and the drug will be drawn by the prestel in the operating room. (double blinded) All patients will be examined on the 1st and 7th day after the procedure for interior chamber reaction and intraocular pressure measurement. Full ophthalmological examination and OCT will be done again in 4, 8 and 12 weeks. Intervention group: In the second intervention group, intravitreal triamcinolone acetonide 0.025 ml (1 mg) ((Holzkirchen, Germany) - off label drug) will be added to the first IVB injection with a separate syringe. In both groups, the injection is done in one eye (the eye with macular thickness above 500 microns). All injections will be performed by a surgeon. The injection is performed after local anesthesia with the help of a 29-gauge needle. Randomization of the eyes is done by the block randomization method and with the help of STATA software. The patient and the surgeon are not aware of the type of injected drug and the drug will be drawn by the prestel in the operating room. (double blinded) All patients will be examined on the 1st and 7th day after the procedure for interior chamber reaction and intraocular pressure measurement. Full ophthalmological examination and OCT will be done again in 4, 8 and 12 weeks. BCVA change based on LogMAR chart. Timepoint: BCVA measurement at baseline and at week 12. Method of measurement: Based on Snellen chart. Changes in central macular thickness (CMT). Timepoint: CMT changes at weeks 4, 8, 12. Method of measurement: Optical coherence tomography. Kerman University of Medical Sciences Approved 2020-04-23 Ethics Committee of Kerman University of Medical Sciences The beginning of Haft Bagh Alavi Blvd, University of Medical Sciences Campus Kerman Kerman Iran (Islamic Republic of)