DME
Conditions
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.
Interventions
DRUGprescription 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.
DRUGprescription 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.
DRUGprescription 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.
DRUGprescription 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.
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual acuity | 6 weeks | Snellen E-chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Centeral macular thickness | 6 weeks | Ophtical Cohearence Tomography |
Countries
Iran
Outcome results
None listed