Comparison of the effectiveness of Intravitreal bevacizumab and intravitreal dexamethasone with intravitreal bevacizumab in the treatment of diabetic macular edema
Assessment and comparison of the efficacy of intravitreal bevacizumab and intravitreal dexamethasone co-therapy with intravitreal bevacizumab monotherapy in the treatment of patients with persistent diabetic macular edema
Torfeh Medical Center (a tertiary referral eye center)
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) patients with type 2 diabetes mellitus, 2) at least 18 years of age, 3) BCVA>20/400, 4) persistent DME: 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 bevacizumab injections
Exclusion criteria:
Panretinal photocoagulation (PRP), any intraocular surgery, or intravitreal steroids within the temporal vicinity of the study period; previous Pars Plana vitrectomy; intraocular pressure (IOP)>21, diagnosed glaucoma, or history of a steroid-induced rise in IO; concomitant retinal disorder causing macular edema; present vitreous hemorrhage, media opacities, ocular inflammation; myopia ≥ 6D; and poor quality OCT images.
Intervention groups
Group 1: three monthly intravitreal injections of bevacizumab (1.25 mg)
Group 2: three monthly intravitreal injections of bevacizumab (1.25 mg) + intravireal dexamethasone (200 micrograms)
Main outcome variables
1- Best-corrected visual acuity
2- Central macular thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220328054362N1
Registration date:2022-08-22, 1401/05/31
Registration timing:retrospective
Last update:2022-08-22, 1401/05/31
Update count:0
Registration date
2022-08-22, 1401/05/31
Registrant information
Name
Hosein Nouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 5952
Email address
hosein.nouri.2018@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2021-08-11, 1400/05/20
Actual recruitment start date
2019-02-04, 1397/11/15
Actual recruitment end date
2021-08-11, 1400/05/20
Trial completion date
2021-12-21, 1400/09/30
Scientific title
Comparison of the effectiveness of Intravitreal bevacizumab and intravitreal dexamethasone with intravitreal bevacizumab in the treatment of diabetic macular edema
Public title
Intravitreal bevacizumab alone or in combination with intravitreal dexamethasone for the treatment of diabetic macular edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
54
More than 1 sample in each individual
Number of samples in each individual:
2
Individuals' eyes were the samples in this study; from each individual one or both eyes were recruited, subject to the eye(s) fulfilling the recruitment criteria
Actual sample size reached:
81
More than 1 sample in each individual
Actual sample size in each individual:
2
Individuals' eyes were the samples in this study; from each individual one or both eyes were recruited, subject to the eye(s) fulfilling the recruitment criteria.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Science