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IRCT20200720048150N1 IRCT 2020-10-28 Ahvaz University of Medical Sciences The efficacy of oral doxycycline with Bevacizumab in diabetes The efficacy of using oral doxycycline with intravitreal Bevacizumab injection in diabetic patients with clinically significant macular edema 2018-10-23 anticipated 60 Complete https://irct.ir/trial/51179 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization was performed using the online software www.random.org. The random sequence of numbers was generated by a researcher external to the study team and concealment of the allocation was assured until the moment of the intervention, stored in opaque envelopes. The patients were allocated to the intervention group (IG) or to the control group (CG) by a researcher who did not apply the intervention or evaluated the outcomes. Intervention group: patients received 1.25 mg IV injection of bevacizumab (Avastin, Genetech Co, San Francisco, USA) along with oral doxycycline (200 mg per day) (Hakim Pharmaceutical Co, Iran) for 4 months. Control group: control group received 1.25 mg bevacizumab (Avastin, Genetech Co, San Francisco, USA) IV injection. 3 Condition 1: Diabetes, Clinically significant macular edema. Condition 2: Diabetes, Clinically significant macular edema. Intervention 1: Intervention group: patients received 1.25 mg IV injection of bevacizumab (Avastin, Genetech Co, San Francisco, USA) along with oral doxycycline (200 mg per day) (Hakim Pharmaceutical Co, Iran) for 4 months. Intervention 2: Control group: control group received 1.25 mg bevacizumab (Avastin, Genetech Co, San Francisco, USA) IV injection. Yes - There is a plan to make this available What will be shared: All individual participant data (IPD) consisting patient's general characteristics, efficacy of treatment and final conclusion are accessible for applicants When: All individual participant data (IPD) have been accessible for applicants from 5th June 2020 To whom: Data products from this study will be made available without cost to researchers and analysts. Conditions: Data will be made accessible through a public email (Kasiri-a@ajums.ac.ir) that allows querying as has been set up for a similar project. Where to obtain: Applicants should send email to responsible person (Kasiri-a@ajums.ac.ir). How to obtain: Users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analysis is completed, reporting responsibilities. Comments:
public Ali Kasiri
Department of Ophthalmology, Faculty of Medicine, Infectious Ophthalmic Research Center, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz
Ahvaz Iran (Islamic Republic of) 15794- 61357 0098 33339196 Kasiri-a@ajums.ac.ir Ahvaz University of Medical Sciences scientific Ali Kasiri
Department of Ophthalmology, Faculty of Medicine, Infectious Ophthalmic Research Center, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz
Ahvaz Iran (Islamic Republic of) 15794- 61357 0098 33339196 Kasiri-a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Diabetic patients with confirmed Clinically Significant Macular Edema no limit no limit Both Patients with previous history of surgery for retinal detachment Patients with glaucoma Patients with uveitis Patients with macular geographic atrophy Patients with macular scar Patients with gastrointestinal distress E11.3 E10.3 Type 2 diabetes mellitus with ophthalmic complications Type 1 diabetes mellitus with ophthalmic complications Treatment - Drugs Treatment - Drugs Intervention group: patients received 1.25 mg IV injection of bevacizumab (Avastin, Genetech Co, San Francisco, USA) along with oral doxycycline (200 mg per day) (Hakim Pharmaceutical Co, Iran) for 4 months. Control group: control group received 1.25 mg bevacizumab (Avastin, Genetech Co, San Francisco, USA) IV injection. Central macular thickness. Timepoint: Before intervention and 2, 4, 6 and 9 months after intervention. Method of measurement: Optical Coherence Tomography images were generated using the Fast Macular Thickness Scan consisting of six radial scans oriented 30 degrees from one another, each having a 2 mm axial depth and 6 mm transverse length. Each image had 10 μm axial and 20 μm transverse resolutions in tissue and consisted of 1024 axial pixels by 512 transverse pixels with a maximum scan velocity of 400 axial per second. Ahvaz University of Medical Sciences Ahvaz University of Medical Sciences Ahvaz University of Medical Sciences Approved 2019-03-16 Ethical committee of Ahvaz University of Medical Sciences International Affairs Office, Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz , Iran Ahvaz Khouzestan Iran (Islamic Republic of)