Overview

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

Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cairo University
Treatments:
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Diclofenac
Endothelial Growth Factors
Ranibizumab
Criteria
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