Status:
COMPLETED
Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab
Lead Sponsor:
Shahid Beheshti University of Medical Sciences
Conditions:
DME
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Purpose: To evaluate the short-term effect of adding topical ketorolac to the management of diabetic macular edema (DME) with intravitreal bevacizumab (IVB). Setting: Ophthalmology department of Imam...
Eligibility Criteria
Inclusion
- BCVA≤20/40 and BCVA 20/400 and better
- History of at least 1 intra-viteral bevacizumab (IVB) in the last 2 months
- Requires 2 IVB in the next 12 weeks
- Macular thickness \>300 μm
- NO Other eye diseases
- Media clarity , pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
Exclusion
- hgb A1c\> 8
- high risk PDR
- Macular edema due to a cause other than diabetic retinopathy
- Any other ocular condition that visual acuity would not improve from resolution of edema (eg.foveal atrophy)
- Prior treatment with intravitreal or peribulbar corticosteroid injection during last 3months
- History of macular photocoagulation during the last 6 months
- intraocular surgery(except cataract surgery)
- Cataract extractionin less than 6 months ago
- Uveitis ,NVG ,exudative AMD, HR PDR.
- Uncontrolled glaucoma
- Vitreomacular traction or epiretinal membrane
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04119921
Start Date
January 1 2018
End Date
June 20 2020
Last Update
February 23 2021
Active Locations (1)
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1
Ophthalmic Research Center
Tehran, Iran