Comparison of intravitreal Bevacizumab (Avastin) injection alone or in combination with Diclofenac in the treatment of diabetic macular edema
Phase 3
- Conditions
- Diabetic retinopathy.Diabetic retinopathy
- Registration Number
- IRCT201512144786N3
- Lead Sponsor
- Isfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
Patients with these criteria were enrolled: diagnosed as center involving diabetic macular edema (DME), have no history of previous surgery, intraocular injection, diagnosis of glaucoma or ocular hypertension, visual acuity between 20/320 to 20/40, absence of iris neovascularization and significant opacities of ocular media, who are not monocular and are not pregnant. The exclusion criteria were: any previous hypersensitivity reaction to Bevacizumab or Diclofenac, complications such as endophthalmitis or intraocular pressure rise, refusal of patient or his/her non-cooperation in follow ups.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Central macular thickness. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Optical coherence tomography.;Macular volume. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Optical coherence tomography.;Best corrected visual acuity. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Snellen chart.
- Secondary Outcome Measures
Name Time Method Refractive error. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Auto refractometer.;Intraocular pressure. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Goldmann tonometer.