Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema (MPL)

Al Hadi Hospital

Status and phase: Completed; Phase 4

Conditions: Diabetic Macular Edema

Treatments: Other: micropulsed yellow laser; Drug: Aflibercept Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03866746

AlHadi Hospital

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

51 participants in 2 patient groups

Group A

Active Comparator group

Description:

received aflibercept injections alone

Treatment:

Drug: Aflibercept Injection

Group B

Experimental group

Description:

received 3 aflibercept injections followed by micropulsed laser

Treatment:

Other: micropulsed yellow laser

Drug: Aflibercept Injection