Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab
1 other identifier
interventional
26
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 2, 2019
CompletedFirst Posted
Study publicly available on registry
October 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2020
CompletedFebruary 23, 2021
October 1, 2019
5 months
October 2, 2019
February 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
visual acuity
Snellen E-chart
6 weeks
Secondary Outcomes (1)
Centeral macular thickness
6 weeks
Study Arms (4)
usage of topical ketorolac in group1
ACTIVE COMPARATORusage of 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
ACTIVE COMPARATORusage of 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
ACTIVE COMPARATORusage of 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
ACTIVE COMPARATORusage of artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval
Interventions
topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ophthalmic Research Center
Tehran, Iran
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of ophthalmic research center
Study Record Dates
First Submitted
October 2, 2019
First Posted
October 9, 2019
Study Start
January 1, 2018
Primary Completion
June 1, 2018
Study Completion
June 20, 2020
Last Updated
February 23, 2021
Record last verified: 2019-10