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

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: DME

Treatments: Drug: prescription topical ketorolac in group 2; Drug: prescription topical ketorolac in group 1; Drug: prescription artificial tear in group1; Drug: prescription artificial tear in group 2

Study type: Interventional

Funder types: Other

Identifiers

NCT04119921

97377

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

26 participants in 4 patient groups

usage of topical ketorolac in group1

Active Comparator group

Description:

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

Treatment:

Drug: prescription topical ketorolac in group 1

usage of artificial tear in group 2

Active Comparator group

Description:

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

Treatment:

Drug: prescription artificial tear in group 2

usage of artificial tear in group 1

Active Comparator group

Description:

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

Treatment:

Drug: prescription artificial tear in group1

usage of topical ketorolac in group2

Active Comparator group

Description:

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

Treatment:

Drug: prescription topical ketorolac in group 2