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

Hospital Hietzing50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Retinal Edema

Interventions

Ranibizumab 0.5 MG/0.05 ML Intraocular SolutionDRUG

Focal laser treatment will be performed using argon laser photocoagulation (VISULAS 532s®, Carl Zeiss Meditec) operating at 532nm and Ranibizumab 0.5 MG/0.05 ML Intraocular Solution. Ranibizumab 0.5 MG/0.05 ML Intraocular Solution

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Hietzing Hospital

Vienna, Austria

Outcomes

Primary Outcomes

Visual acuity

Functional alterations will be followed during treatment phase, essential for verification of treatment success. Units: Snellen equivalents

Time frame: 1 year

Secondary Outcomes

Additional morphological characteristics in spectral Domain SD-OCT

Intraretinal morphological features found in SD- OCT Imaging (i.e. intraretinal morphological changes senn on SD-OCT).

Time frame: 1 year

Central retinal thickness

Morphological alterations will be followed during treatment phase, essential for verification of treatment success. Units: Micrometer (retinal thickness)

Time frame: 1 year

Data from ClinicalTrials.gov

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