Diabetic Macular Edema
Conditions
Keywords
Diclofenac, Ranibizumab, Diabetic Macular Edema
Brief summary
The study aims to compare the effect of intravitreal non steroidal anti inflammatory (Diclofenac) versus the standard treatment of diabetic macular edema, intravitreal anti vascular endothelial growth factor (Ranibizumab), measuring central macular thickness changes and best corrected visual acuity.
Detailed description
Thirty eyes of diabetic patients with diabetic retinopathy with macular edema will be randomized using simple randomization method into two groups; A and B. Group A will undergo intravitreal injection of 500µg Diclofenac, repeated monthly for 3 months. Electroretinogram will be performed before the injections, 4 weeks after first injection and 4 weeks after third injection to assess any risk of toxicity. Colored photography and fundus fluorescein angiography will be done before the first injection to assess the extent of macular leakage at late phases, and to exclude cases with macular ischemia. Optical coherence tomography will be done to measure the central macular thickness, before the first injection, and before each injection. Visual acuity will be assessed before and after each injection. Group B will undergo intravitreal injection of 0.5 mg Ranibizumab, repeated monthly for 3 months. Colored photography and fundus fluorescein angiography will be done before the first injection to assess the extent of macular leakage at late phases, and to exclude cases with macular ischemia. Optical coherence tomography will be done to measure the central macular thickness, before the first injection, and before each injection. Visual acuity will be assessed before and after each injection. All patients will be examined weekly for one month and then monthly for three months after the injection. At every visit, visual acuity, intraocular pressure, and a dilated fundus examination will be performed. All patients will be required to instill topical antibiotic Gatifloxacin postoperatively 3 times per day for 5 days. Patients will be warned about the signs and symptoms of complications (endophthalmitis, retinal detachment, vitreous hemorrhage, lens trauma) and asked to seek medical attention immediately.
Interventions
DRUGDiclofenac Sodium 0.1 ml containing 500µg
15 eyes will receive intravitreal 0.1 ml containing 500µg of Diclofenac Sodium monthly for three months
DRUGRanibizumab 0.5 mg Solution for Injection
15 eyes will receive intravitreal 0.5 mg of Ranibizumab monthly for three months
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diabetic retinopathy with non tractional maculopathy, where central macular thickness is greater than 400µm, with and without cystic changes. 2. Diabetes Mellitus type one and two 3. Best Corrected Visual Acuity \> 0.1 LogMar
Exclusion criteria
1. Patients treated with diclofenac, Ranibizumab or Bevacizumab in the past 3 months 2. Patients with a history of branch or central retinal artery occlusion 3. Patients without clear media and adequate pupillary dilation that allows proper fundoscopy and imaging, and patients who are not complaint with the regular visits. 4. Visual Significant Cataract 5. Evidence of vitreomacular traction or macular ischemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in best corrected visual acuity | 3 months of follow up | Measuring the best corrected visual acuity |
| Change in central macular thickness | 3 months of follow up | Measuring the change in central macular thickness using Optical Coherence Tomography |
Countries
Egypt
Contacts
Primary ContactIyad A Goussous, MSc
Outcome results
None listed