Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Ophthalmic Research Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
|
|
Active Comparator: 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.
|
artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
|
|
Active Comparator: 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
|
topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
|
|
Active Comparator: 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
|
artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual acuity
Time Frame: 6 weeks
|
Snellen E-chart
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Centeral macular thickness
Time Frame: 6 weeks
|
Ophtical Cohearence Tomography
|
6 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Macular Edema
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Ketorolac
- Lubricant Eye Drops
- Ketorolac Tromethamine
Other Study ID Numbers
- 97377
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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