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Completed

NCT Number: NCT04119921

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.

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Key information

Conditions

DME

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ophthalmic Research Center

Tehran, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prescription topical ketorolac in group 1

Drug

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

Drug

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

Drug

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

Drug

topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.

Primary outcomes

  1. visual acuity

    Time frame: 6 weeks

    Snellen E-chart

Secondary outcomes

  1. Centeral macular thickness

    Time frame: 6 weeks

    Ophtical Cohearence Tomography

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Oct 9, 2019
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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