NCT03458923

Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Diclofenac Sodium 0.1 ml containing 500µg	15 eyes will receive intravitreal 0.1 ml containing 500µg of Diclofenac Sodium monthly for three months
DRUG	Ranibizumab 0.5 mg Solution for Injection	15 eyes will receive intravitreal 0.5 mg of Ranibizumab monthly for three months

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2018-03-08
• Last updated: 2018-03-08

Locations

1 site across 1 country: Egypt