Diabetic Macular Edema
Conditions
Brief summary
This study is a double-blind randomized clinical trial in Diabetic patients (type 2) over 18 years of age who have diabetic macular edema with involvement of the central 1 millimeter (central macular thickness is more than 300 μm) and BCVA 20/30 or less who visit the retina clinic of Labbafinejad Hospital Are studied. (In patients with bilateral macular edema, only one eye is included in the study.) Complete ocular examinations (including best corrected visual acuity - anterior segment - intraocular pressure - dilated pupil funduscopy with severity of diabetic retinopathy), optical coherence tomography (OCT), EDI-OCT( Enhanced Depth Imaging Optical Coherence Tomography ) - as well as Optical coherence tomography angiography (OCTA ) are performed for all patients at baseline. Blood tests are also taken from patients for fasting blood sugar and HbA1C. Patients are then randomly divided into two groups. The first group is treated with injections of 1.25 mg of intravitreal bevacizumab monthly for 3 months (months 0, 1 and 2) with topical drops of Timolol twice a day and Dorzolamide twice a day. For the second group (control group), 3 injections of 1.25 mg of intravitreal bevacizumab monthly with artificial tears (twice a day as a placebo) are prescribed. Patients in both groups are visited 1 month after the third basic intravitreal bevacizumab (IVB) injection and complete ophthalmology examinations are performed and central thickness of macula is recorded based on the patient's OCT as well as the need for IVB re-injection. EDI (Enhanced Depth Imaging)-OCT and OCTA are performed again for all patients.
Interventions
DRUGInjections of 1.25 mg of intravitreal bevacizumab with Timolol and Dorzolamide
31 cases in intervention group receive injections of 1.25 mg of intravitreal bevacizumab monthly for 3 months (months 0, 1 and 2) with topical drops of Timolol twice a day and Dorzolamide twice a day
DRUGInjections of 1.25 mg of intravitreal bevacizumab with artificial tears
31 cases in control group receive intravitreal injection of 1.25 mg bevacizumab monthly for 3 months (months 0, 1 and 2) plus artificial tears (twice a day as a placebo)
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with Diabetic Melitus type 2 * Patients with center-involving diabetic macular edema (central macular edema \> 300 micrometer) * Patients have diabetic retinopathy at the stage of nonproliferative diabetic retinopathy (NPDR) or early PDR (proliferative diabetic retinopathy) or regressed PDR * In patients with bilateral macular edema, only one eye is included in the study.
Exclusion criteria
* uncomplicated cataract surgery * history of cataract surgery during last 4 months * history of Panretinal Photocoagulation (PRP) during last 4 months * any retinochoroidal disease except Diabetic retinopathy * optic disc pathology * patient with high-risk PDR or advanced PDR * one-eye patients * patient with glaucoma or uveitis * pregnant or lactating patients * patients whom topical Timolol or Dorzolamide are prohibited for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central macular thickness | 1 month | Measured by EDI-OCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity (BCVA) | 1 month | By ophthalmology resident with subjective and objective refraction |
Countries
Iran
Outcome results
None listed