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IRCT20220416054548N1 IRCT 2022-05-23 Esfahan University of Medical Sciences Determining the association of response rate to Intravitreal injection of bevacizumab and macular vessel density in patients with diabetic macular edema using optical coherence tomography angiography (OCT-A) Determining the association of response rate to Intravitreal injection of bevacizumab and macular vessel density in patients with diabetic macular edema using optical coherence tomography angiography (OCT-A) in outpatients referred to Feyz Hospital 2022-05-22 anticipated 70 Complete https://irct.ir/trial/62974 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Determining the association of response rate to Intravitreal injection of bevacizumab and macular vessel density in patients with diabetic macular edema using optical coherence tomography angiography (OCT-A) in outpatients referred to Feyz Hospital. Intervention group: The present study is a longitudinal study with a pre-post design. Samples are selected sequentially from outpatients to ophthalmology clinics who have non-proliferative diabetic retinopathy with diabetic macular edema based on inclusion criteria and OCT is taken from them. Women with a central macular thickness (CMT) above 305 μm and men a CMT above 320 μm were included in the study. First, comprehensive examinations were performed on the patients and their information was recorded. After that OCT-A images was taken from both eyes of the patients in 3 × 3 mm slabs (to remove projection artifacts, the slabs were changed 6 × 6 mm to 3 × 3 mm). The level of vascular density was determined in the superficial and deep layers and superior and inferior hemifield defects were determined in the macular and parachute areas. After that, the patients who were candidates for treatment based on the standard protocols of diabetic macular edema (DME) treatment, in a sterile organized environment, 1.25 mg of bevacizumbe was injected intravenously with a distance of 3–4 mm from the limbus. For any of patients, the injections were continued up to three times every month. Finally, one month after the last injection, OCT-A scan was taken again and the vascular density in the superficial and deep layers was examined and compared before and after the injection. In this study, a 10% reduction in CMT was considered to be an appropriate level of response to treatment. The used imaging system in our study was RTVue XR Avanti (Optovue Inc., Fremont, CA, USA).. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Need group consultation
public Mahya Ghazi
Central Headquarters, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 ghazyzeynab@yahoo.com Esfahan University of Medical Sciences scientific Mahya Ghazi
Central Headquarters, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 ghazyzeynab@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Having type 1 or 2 diabetes Central macular edema based on Heidelberg's clinical examination and OCT in one or both eyes (at least 305 μm in women and 320 μm in men) Best modified view less than or equal to 10/7 No history of laser in the patient's eye Moderate to severe non-proliferative diabetic retinopathy with diabetic macular edema Transparent media to the extent that it does not interfere with the quality of images and their analysis (SSI: signal strength index: 37-40) 18 years no limit Both History of retinal vascular obstructive diseases History of intraocular injection in the last 6 months History of intraocular and retinal laser in the affected eye in the last 12 months Decreased vision following any ocular pathology other than diabetic retinopathy High Myopia (≥ -8) History of eye surgery in the last 6 months Uncontrolled glaucoma (IOP ≥ 30 mmHg despite maximal treatment) Uncontrolled diabetes Uncontrolled blood pressure (SBP ≥180 mmHg or DBP ≥100 mmHg Connective tissue diseases E08.321 Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema Treatment - Drugs Intervention group: The present study is a longitudinal study with a pre-post design. Samples are selected sequentially from outpatients to ophthalmology clinics who have non-proliferative diabetic retinopathy with diabetic macular edema based on inclusion criteria and OCT is taken from them. Women with a central macular thickness (CMT) above 305 μm and men a CMT above 320 μm were included in the study. First, comprehensive examinations were performed on the patients and their information was recorded. After that OCT-A images was taken from both eyes of the patients in 3 × 3 mm slabs (to remove projection artifacts, the slabs were changed 6 × 6 mm to 3 × 3 mm). The level of vascular density was determined in the superficial and deep layers and superior and inferior hemifield defects were determined in the macular and parachute areas. After that, the patients who were candidates for treatment based on the standard protocols of diabetic macular edema (DME) treatment, in a sterile organized environment, 1.25 mg of bevacizumbe was injected intravenously with a distance of 3–4 mm from the limbus. For any of patients, the injections were continued up to three times every month. Finally, one month after the last injection, OCT-A scan was taken again and the vascular density in the superficial and deep layers was examined and compared before and after the injection. In this study, a 10% reduction in CMT was considered to be an appropriate level of response to treatment. The used imaging system in our study was RTVue XR Avanti (Optovue Inc., Fremont, CA, USA). Blood sugar levels. Timepoint: Before the intervention. Method of measurement: blood test. Blood pressure. Timepoint: Before the intervention. Method of measurement: Physical examination. Severity of retinopathy. Timepoint: Before the intervention. Method of measurement: Examination with slit lamp. The best modified vision. Timepoint: Before the intervention. Method of measurement: Physical examination. Eye pressure. Timepoint: Before the intervention. Method of measurement: Measurement with tonometer. The central thickness of the macula. Timepoint: Before the intervention and 1 month after the last injection. Method of measurement: OCT. FAZ level. Timepoint: Before the intervention and 1 month after the last injection. Method of measurement: OCT-A. Vascular density of the surface layer. Timepoint: Before the intervention and 1 month after the last injection. Method of measurement: OCT-A. Deep layer vascular density. Timepoint: Before the intervention and 1 month after the last injection. Method of measurement: OCT-A. Total vascular density. Timepoint: Before the intervention and 1 month after the last injection. Method of measurement: OCT-A. The central thickness of the macula. Timepoint: One month after the last injection. Method of measurement: OCT. FAZ level. Timepoint: One month after the last injection. Method of measurement: OCT-A. Vascular density of the surface layer. Timepoint: One month after the last injection. Method of measurement: OCT-A. Deep layer vascular density. Timepoint: One month after the last injection. Method of measurement: OCT-A. Total vascular density. Timepoint: One month after the last injection. Method of measurement: OCT-A. Esfahan University of Medical Sciences Approved 2021-12-10 Ethics Committee of Isfahan University of Medical Sciences Central Headquarters, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St. Esfahan Isfehan Iran (Islamic Republic of)