NCT03866746

Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema

Aflibercept With Adjuvant Micro-Pulsed Yellow Laser Versus Aflibercept Monotherapy in Treatment of Diabetic Macular Edema.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Al Hadi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

prospective study evaluating the impact of subthreshold micropulsed laser on the number of Aflibercept injections when used as an adjuvant therapy in eyes with diabetic macular edema.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Aflibercept Injection	Group A;Under complete aseptic conditions; intravitreal aflibercept injections with dose of 2 mg/0.05 mL per injection was given for the patients. Patients were scheduled to receive 3 loading injections at monthly interval. At the 3rd month; further treatment was planned pro re nata (PRN) according to the response. Injections were discontinued when the CMT reached 250 µm or less. If there was no change in the CMT after two consecutive injections; patients shifted to other line of treatment. Reinjection was continued for the other eyes with re-evaluation of the response every month.In group B Patients received the initial 3 monthly loading doses of IVI of aflibercept followed by MPL therapy (within one week after the 3rd injection). Patients were scheduled for follow-up monthly. Injection followed by MPL was then repeated according to the response as in group A.
OTHER	micropulsed yellow laser	Micropulse yellow IQ 577nm laser (Iridex Corporation, Mountain View, CA, USA) was employed. The Area Centralis lens (laser spot size magnification 0.94) was utilized with 400 mw power, 200μm spot size and 200 ms pulse duration with 5% duty cycle after micropulse mode activation. Laser was applied on clinically visible thickened macula with different number of confluent non- spacing shots in 7x7 grids. Care was taken to begin treatment outside the foveal avascular zone and not to treat the fovea when there was no visible reaction. If there was any visible reaction; treatment was stopped and the power was reduced until there was no visible reaction.

Timeline

• Start date: 2017-05-08
• Primary completion: 2017-06-21
• Completion: 2018-12-28
• First posted: 2019-03-07
• Last updated: 2019-07-05

Locations

1 site across 1 country: Kuwait