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OpenTrials
Completed

NCT Number: NCT03866746

Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AlHadi hospital

Hawalli, AlJabryia, 123, Kuwait

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aflibercept Injection

Drug

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

micropulsed yellow laser

Other

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.

Primary outcomes

  1. the number of intravitreal injections

    Time frame: 18th month follow-up.

    the total number of intravitreal aflibercept injections were recorded

  2. Central macular thickness

    Time frame: 18 month

    in um

Secondary outcomes

  1. best corrected visual acuity measured in ETDRS.

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Al Hadi Hospital

Other

Registry information

Official study title

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

Acronym: MPL

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 7, 2019
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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