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

DME Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119921
• Other study ID #: 97377
• Status: Completed
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• DME
• Macular Edema

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