Diabetic Macular Edema. Diabetic Retinopathy
Conditions
Interventions
Intervention 1: Intervention group: Monthly intravitreal bevacizumab+ sinarolac topical eye drop. Intervention 2: Control group: Monthly intravitreal injection+ artificial tear topical eye drop.
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diabetic patients = 18 years who had center-involved diabetic macular edema (central macular thickness=300µ with subretinal or intraretinal fluid) with accompanying decrease in visual acuity (20/200=VA=20/40)
Exclusion criteria
Exclusion criteria: Presence of proliferative diabetic retinopathy (PDR) Macular ischemia based on fluorescein angiography Any other macular pathology which could inhibit visual acuity improvement History of any intraocular surgery other than uncomplicated phacoemulsification in the preceding 6 months Panretinal photocoagulation within 6 months or macular photocoagulation within 3 month of study entry Intravitreal injection of anti-vegf drugs within 3 months or intravitreal steroid within 6 months of randomization History of cerebrovascular accident or myocardial infarction in the past 6 months Uncontrolled glaucoma (IOP> 24 mmHg on anti-glaucoma medication) Uncontrolled hypertension (systolic blood pressure>160 or diastolic blood pressure >100mmHg) Uncontrolled diabetes (HbA1c>12).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of central macular thickness changes. Timepoint: 0, week 4, week 8, week 14, week 20, week 26. Method of measurement: By optical coherence tomography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity improvement. Timepoint: 0, week 4, week 8, week 14, week 20, week 26. Method of measurement: E-chart and then conversion to logMAR. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHomayoun Nikkhah
Shahid Beheshti University of Medical Sciences
Outcome results
None listed