Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

— MPL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03866746
• Other study ID #: AlHadi Hospital
• Status: Completed
• Phase: Phase 4
• Start date: May 8, 2017
• Est. completion date: December 28, 2018

Study information

• Verified date: July 2019
• Source: Al Hadi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 28, 2018
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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.

Locations

Country	Name	City	State
Kuwait	AlHadi hospital	?awalli	AlJabryia

Sponsors (1)

Lead Sponsor	Collaborator
Al Hadi Hospital

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of intravitreal injections	the total number of intravitreal aflibercept injections were recorded	18th month follow-up.
Primary	Central macular thickness	in um	18 month
Secondary	best corrected visual acuity measured in ETDRS.		18 months