Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab
NCT ID: NCT04119921
Last Updated: 2021-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
26 participants
INTERVENTIONAL
2018-01-01
2020-06-20
Brief Summary
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Setting: Ophthalmology department of Imam Hossein and Torfe Medical Centers. Ophthalmic Epidemiology Research Center of Shahid Beheshti University of Medical Sciences Methods: In a randomized double-masked placebo-controlled crossover clinical trial, all eyes with DME with best-corrected visual acuity (BCVA) between 20/40 and 20/400 were included. They should have had at least one intravitreal anti-VEGF injection in the past 2 months. They were randomized into two groups. Both groups received two IVB injections with 6-week interval. One group received topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. The other group received the opposite medications. Best-corrected visual acuity (BCVA) and central macular thickness (CMT) evaluations were repeated at the termination of each treatment period i.e. at 6 and 12 weeks. The main outcome measure was BCVA changes in logMAR and the second outcome was CMT changes. The interim analysis of this study is presented in this report.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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usage of topical ketorolac in group1
usage of topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
prescription topical ketorolac in group 1
topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
usage of artificial tear in group 2
usage of artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
prescription artificial tear in group 2
artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
usage of artificial tear in group 1
usage of topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval
prescription artificial tear in group1
topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
usage of topical ketorolac in group2
usage of artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval
prescription topical ketorolac in group 2
artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
Interventions
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prescription topical ketorolac in group 1
topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
prescription artificial tear in group 2
artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
prescription topical ketorolac in group 2
artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
prescription artificial tear in group1
topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
30 Years
75 Years
ALL
Yes
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Zahra Rabbani Khah
Head of ophthalmic research center
Locations
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Ophthalmic Research Center
Tehran, , Iran
Countries
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Other Identifiers
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97377
Identifier Type: -
Identifier Source: org_study_id
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