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IRCT20220328054362N1 IRCT 2022-08-22 Shahid Beheshti University of Medical Sciences Intravitreal bevacizumab alone or in combination with intravitreal dexamethasone for the treatment of diabetic macular edema Comparison of the effectiveness of Intravitreal bevacizumab and intravitreal dexamethasone with intravitreal bevacizumab in the treatment of diabetic macular edema 2019-02-04 anticipated 54 Complete https://irct.ir/trial/63781 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Diabetic macular edema. Intervention 1: Routine intervention group: Three consecutive monthly intravitreal injection of 1.25 mg bevacizumab (Avastin®100mg/4ml Vial, Roche Pharma, Switzerland). Intervention 2: Additive intervention group: three consecutive monthly intravitreal co-injections of 1.25 mg bevacizumab (Avastin®100mg/4ml Vial, Roche Pharma, Switzerland) and 200 μg of intravitreal dexamethasone (Dexon® 8mg/2ml Amp, Sinadarou, Iran). 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 anonymized data will not be publicly available but upon reasonable request,e.g., for pooled analysis, will be sent privately.
public Saeed Karimi
Ibn-Sina St, District 12
Tehran Iran (Islamic Republic of) 1149847514 +98 21 7762 6559 dr.saeedkarimi@gmail.com Shahid Beheshti University of Medical Sciences scientific Saeed Karimi
Ibn-Sina St, District 12
Tehran Iran (Islamic Republic of) 1149847514 +98 21 7762 6559 dr.saeedkarimi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) patients with type 2 diabetes mellitus at least 18 years of age best-corrected visual acuity >20/400 persistent DME - i.e., patients who had received at least 3 intravitreal injections of Bevacizumab given at monthly intervals but still had a CMT >300 microns caused by intraretinal or subretinal fluid as well as a reduction of <10% of baseline CMT based on spectral domain OCT (SD-OCT) measured 1 month after at least 3 intravitreal bevacizimab injections Time from the last intravitreal injection more than 1 month and less than 2 months 18 years no limit Both Patients who had undergone laser photocoagulation (PRP) during the last 3 months or needed PRP until the end of the study patients who had received intravitreal steroids within the last 6 months Patients who had undergone any intraocular surgery during the last 3 months Patients with previous Pars Plana vitrectomy Patients with intraocular pressure (IOP)>21 or known cases of primary or secondary glaucoma or history of steroid responding Patients with other concomitant retinal disorders that could give rise to macular edema Patients with vitreous hemorrhage, media opacities, ocular inflammation myopia ≥ 6D those with poor quality OCT images E08.311 Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema Treatment - Drugs Treatment - Drugs Routine intervention group: Three consecutive monthly intravitreal injection of 1.25 mg bevacizumab (Avastin®100mg/4ml Vial, Roche Pharma, Switzerland) Additive intervention group: three consecutive monthly intravitreal co-injections of 1.25 mg bevacizumab (Avastin®100mg/4ml Vial, Roche Pharma, Switzerland) and 200 μg of intravitreal dexamethasone (Dexon® 8mg/2ml Amp, Sinadarou, Iran) Best-corrected visual acuity (Logarithm of the Minimum Angle of Resolution). Timepoint: before intervention and 1 month after the last injection. Method of measurement: Snellen chart. Central macular thickness. Timepoint: before intervention and 1 month after the last injection. Method of measurement: Spectral-domain optical coherence tomography (SD-OCT; 6 × 6 mm images taken with the macular cube protocol on the Heidelberg SD-OCT). Incidence of intraocular pressure rise (adverse event). Timepoint: 1 month after the last injection. Method of measurement: Goldmann applanation tonometry. Incidence of other adverse events (endophthalmitis, uveitis, vitreous hemorrhage, rupture, and retinal detachment). Timepoint: throughout the intervention and one-month follow-up periods. Method of measurement: Reported by participants - Relevant diagnostic workup upon presentation of symptoms in participants' eyes. Shahid Beheshti University of Medical Sciences Approved 2022-03-15 Ethics committee of Shahid Beheshti University of Medical Science 7th Floor, Bldg No. 2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)