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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03458923
• Other study ID #: Iyad Goussous
• Status: Recruiting
• Phase: Phase 4
• First received: February 26, 2018
• Last updated: March 2, 2018
• Start date: January 2015
• Est. completion date: June 2018

Study information

• Verified date: March 2018
• Source: Cairo University
• Contact: Iyad A Goussous, MSc
• Phone: 00201062453343
• Email: dr.iyad.goussous[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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
• Ranibizumab 0.5 mg Solution for Injection
15 eyes will receive intravitreal 0.5 mg of Ranibizumab monthly for three months

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in best corrected visual acuity	Measuring the best corrected visual acuity	3 months of follow up
Primary	Change in central macular thickness	Measuring the change in central macular thickness using Optical Coherence Tomography	3 months of follow up