Diabetic macular edema, diabetic retinopathy, melatonin supplement.
Conditions
Interventions
Intervention 1: Intervention group: combination therapy of Melatonin supplemet - Jalinous Co. 10mg daily and intravitreal Aflibercept - Tyalia, CinnaGen Co1.25 mg injection (3 monthly injection and th
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1C=6.5%) 40-65 years of age Diabetic retinopathy of at least moderate degree
Exclusion criteria
Exclusion criteria: History of vitrectomy in the studied eye History of prior laser treatment or anti-VEGF therapy in the past 3 months Any suspicion of CNV Patients participating in any other investigational drug study Pregnant or nursing patients History of melatonin usage antidepressants or antipsychotics illicit drug use night shift work history of dementia or memory impairment uncontrolled congestive heart failure or recent hospitalization for cardiac condition (6 months) chronic obstructive pulmonary disease requiring oxygen ongoing treatment for major medical problems such as cancer history of severe hypoglycemia defined as hypoglycemic episodes requiring assistance from others within the past six months Significant depressive symptoms use of sedatives and hypnotics clinically significant epiretinal membranes, clinically significant lens opacities, or cystoid macular edema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central Macular Thickness. Timepoint: Before intervention and 3,4,5,6 months after intervention. Method of measurement: Triton Swept Source OCT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of intravitreal Aflibercept injection. Timepoint: At the end of 6 months of follow up. Method of measurement: Calculating number of intravitreal Aflibercept injection.;Visual acuity. Timepoint: Before intervention and 3,4,5,6 months after entering the study. Method of measurement: Using snellen chart.;Intraocular Pressure. Timepoint: Before intervention and 3,4,5,6 months after entering the study. Method of measurement: Goldmann Applanation Tonometer in mmHg. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHomayoun Nikkhah
Shahid Beheshti University of Medical Sciences
Outcome results
None listed