Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Aflibercept Injection
* Other: micropulsed yellow laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>received aflibercept injections alone | Drug: Aflibercept Injection<br>* 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.<br>* Other names: Micropulsed yellow laser;|
| Experimental: Group B<br>received 3 aflibercept injections followed by micropulsed laser | Drug: Aflibercept Injection<br>* 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.<br>* Other names: Micropulsed yellow laser;Other: micropulsed yellow laser<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best corrected visual acuity measured in ETDRS. |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aflibercept, Anti-VEGFs, micropulsed diode laser, subthreshold