Treatment of Diabetic Macular Edema (DME) With Anti-VEGF and Focal Laser

Hospital Hietzing

Status and phase: Completed; Phase 4

Conditions: Diabetic Retinal Edema

Treatments: Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03590444

EK 10-147-0910

Details and patient eligibility

About

Long-term follow-up of patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) combined focal laser and identification of prognostic morphological characteristics.

Full description

Long-term follow-up of patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) combined focal laser and identification of prognostic morphological characteristics.

Prospective clinical trial (50 treatment-naive eyes) with DME randomized 1:1 receiving intravitreal ranibizumab (0.5 mg/0.05 ml) and prompt grid laser compared to ranibizumab and deferred laser. Morphological characteristics potentially relevant for prognosis were assessed at baseline, month 6, month 9, year 1, 2, 3, 4 and 5 of follow-up.

Grid laser and ranibizumab therapy is expected to be effective in DME management during long-term follow-up. Immediate combined therapy will likely signify a trend of functional superiority in an early disease phase. Intraretinal hyperreflective material in SD-OCT will likely negatively related to BCVA.

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• DME that will be detected clinically and on FA as well as on SD-OCT [diffuse macular edema with central retinal thickness (CRT) ≥300µm involving the center of the macular area]
• Patients will be included into the present study following informed consent
• Best-corrected-visual-acuity (BCVA) between 0.06 (1.2logMAR) and 0.63 (0.20logMAR).

Exclusion criteria

• Eyes with other retinal diseases [i.e. age-related macular degeneration (AMD) and associated choroidal neovascularization (CNV), cystoid macular edema (CME) of other origin (e.g. uveitis, Irvine-Gass syndrome, retinal vein occlusion), or retinal dystrophies]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Prompt laser group

Active Comparator group

Description:

Eyes of eligible patients will be randomized (ratio 1:1) and receive ranibizumab and focal/grid laser on the same day (prompt' group, 25 eyes, 50%). Interventions: ranibizumab and focal/grid laser on the same day \[Ranibizumab (Ranibizumab 0.5 MG/0.05 ML Intraocular Solution\]

Treatment:

Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution

Deferred laser group

Active Comparator group

Description:

Eyes of eligible patients will be randomized (ratio 1:1) and receive ranibizumab and focal/grid laser on one week prior to laser treatment (deferred' group, 25 eyes, 50%). Interventions: ranibizumab and focal/grid laser on one week prior to laser treatment \[Ranibizumab 0.5 MG/0.05 ML Intraocular Solution\]

Treatment:

Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution