Trial | NCT03866746  Report issue

Title

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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    51
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.
Study Started
May 08
2017
Primary Completion
Jun 21
2017
Study Completion
Dec 28
2018
Last Update
Jul 05
2019

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 names: Micropulsed yellow laser

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.

Group A Active Comparator

received aflibercept injections alone

Group B Experimental

received 3 aflibercept injections followed by micropulsed laser

Criteria 

Inclusion Criteria:

older than 18 years old
diagnosed with DME with central macular thickness (CMT) more than 250 µm measured by OCT
best corrected visual acuity (BCVA) between 20/400 and 20/40.

Exclusion Criteria:

patients with intra-ocular surgery as cataract surgery within 6 months
prior intravitreal injection of any drug within the preceding 6 months
panretinal photocoagulation (PRP) within the former 4 months.
Patients with previous macular laser
patients with vitreo-macular traction (VMT) syndrome
severe glaucoma
other retinal vascular diseases
conditions that impede the OCT interpretation
No Results Posted