Treatment of Diabetic Macular Edema (DME) With Anti-VEGF and Focal Laser
- Conditions
- Diabetic Retinal Edema
- Interventions
- Registration Number
- NCT03590444
- Lead Sponsor
- Hospital Hietzing
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prompt laser group Ranibizumab 0.5 MG/0.05 ML Intraocular Solution 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 \[Ranibizumab (Ranibizumab 0.5 MG/0.05 ML Intraocular Solution\] Deferred laser group Ranibizumab 0.5 MG/0.05 ML Intraocular Solution 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 \[Ranibizumab 0.5 MG/0.05 ML Intraocular Solution\]
- Primary Outcome Measures
Name Time Method Visual acuity 1 year Functional alterations will be followed during treatment phase, essential for verification of treatment success. Units: Snellen equivalents
- Secondary Outcome Measures
Name Time Method Additional morphological characteristics in spectral Domain SD-OCT 1 year Intraretinal morphological features found in SD- OCT Imaging (i.e. intraretinal morphological changes senn on SD-OCT).
Central retinal thickness 1 year Morphological alterations will be followed during treatment phase, essential for verification of treatment success. Units: Micrometer (retinal thickness)
Trial Locations
- Locations (1)
Hietzing Hospital
🇦🇹VIenna, Austria