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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04119921
Other study ID # 97377
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date January 1, 2018
Est. completion date June 20, 2020

Study information

Verified date October 2019
Source Shahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date June 20, 2020
Est. primary completion date June 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Iran, Islamic Republic of Ophthalmic Research Center Tehran

Sponsors (1)

Lead Sponsor Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary visual acuity Snellen E-chart 6 weeks
Secondary Centeral macular thickness Ophtical Cohearence Tomography 6 weeks
See also
  Status Clinical Trial Phase
Completed NCT00105404 - Treatment of Diabetic Macular Edema: Triamcinolone Injections Vs. Laser Photocoagulation Phase 3