Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema

NCT03866746 | Completed Phase 4

• 1 other identifier: AlHadi Hospital
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Aflibercept; Anti-VEGFs; micropulsed diode laser; subthreshold

Outcome Measures

Primary Outcomes (2)

• the number of intravitreal injections

  the total number of intravitreal aflibercept injections were recorded

  18th month follow-up.

• Central macular thickness

  in um

  18 month

Secondary Outcomes (1)

• best corrected visual acuity measured in ETDRS.

  18 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

received aflibercept injections alone

Drug: Aflibercept Injection

Group B

EXPERIMENTAL

received 3 aflibercept injections followed by micropulsed laser

Drug: Aflibercept Injection; Other: micropulsed yellow laser

Interventions

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.

Also known as: Micropulsed yellow laser

Group A; Group B

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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Al Hadi Hospital: lead

Study Sites (1)

AlHadi hospital

Hawalli, AlJabryia, 123, Kuwait

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Abeer M Khattab, MD

  Al Hadi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of ophthalmology

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 7, 2019
• Study Start: May 8, 2017
• Primary Completion: June 21, 2017
• Study Completion: December 28, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

KU (1)