Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab

Study Overview
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Brief Summary
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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.

Official Title
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Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab

Conditions
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DME

Intervention / Treatment
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* Drug: prescription topical ketorolac in group 1
* Drug: prescription artificial tear in group 2
* Drug: prescription topical ketorolac in group 2
* Drug: prescription artificial tear in group1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: usage of topical ketorolac in group1<br>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. | Drug: prescription topical ketorolac in group 1<br>* topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.<br>|
| Active Comparator: usage of artificial tear in group 2<br>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. | Drug: prescription artificial tear in group 2<br>* artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.<br>|
| Active Comparator: usage of artificial tear in group 1<br>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 | Drug: prescription artificial tear in group1<br>* topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.<br>|
| Active Comparator: usage of topical ketorolac in group2<br>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 | Drug: prescription topical ketorolac in group 2<br>* artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | Snellen E-chart | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Centeral macular thickness | Ophtical Cohearence Tomography | 6 weeks |