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Purpose: To evaluate the role of adjuvent micropulse laser with Aflibercept injections in the management of treatment naïve centre involving DME, looking at decreased treatment burden and increased efficacy as outcomes.
Methods: This was a prospective, single centre, randomized trial that included 40 eyes (40 patients) with previously untreated centre involved DME. Patients were randomly assigned to receive either Aflibercept plus micropulse laser (group A) or Aflibercept monotherapy (group B).
Patients were randomly distributed in a 1:1 ratio between the two studied groups. Group A received 3 monthly injections of Aflibercept 2 mg/0.05 mL (Eylea; Bayer, Berlin, Germany) as a loading dose, followed one month later by one 577 nm yellow micropulse laser session with monthly PRN Aflibercept injections. Group B received 3 monthly injections of Aflibercept 2 mg/0.05 mL as a loading dose, followed by monthly PRN Aflibercept injections. Patients in both groups were assessed one month after the end of loading phase; At this point, group A received the micropulse laser session and started PRN Aflibercept injections, while group B started PRN Aflibercept injections without receiving the micropulse laser session. After that, both groups were followed for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept plus micropulse laser (group A) | Active Comparator | Overall 40 patients were included in the study; they were randomized into either group A (Aflibercept + Micropulse; 20 patients) or group B (Aflibercept monotherapy; 20 patients). |
|
| Aflibercept monotherapy (group B) | Active Comparator | Overall 40 patients were included in the study; they were randomized into either group A (Aflibercept + Micropulse; 20 patients) or group B (Aflibercept monotherapy; 20 patients). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micropulse laser | Device | Micropulse session details: Mainster focal grid contact lens (×1.05 laser magnification) was used to perform laser. The 577-nm yellow laser (OcuLight SLx, Iridex Corp., Mountain View, California, USA) was used. Fixed treatment parameters were used in all cases: 200-μm spot size, 200-ms exposure duration, 400-mW power, and a 5% duty cycle. Confluent applications with no spacing were administered using 5x5 grid pattern over the entire edematous area including the fovea. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of Aflibercept injections in both groups | The number of Aflibercept injections in both groups | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in visual acuity in both groups. | best corrected visual acuity in both groups at one year. | 12 months |
| The changes in central macular thickness in both groups. | central macular thickness in both groups at one year |
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Inclusion Criteria:
Exclusion Criteria:
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patient data protection
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Aflibercept | Drug | Aflibercept |
|
| 12 months |