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

NCT04119921 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-02-23

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2018-06-01
Completion
2020-06-20

Countries

  • Iran

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04119921 on ClinicalTrials.gov