Diabetic Retinal Edema
Conditions
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.
Interventions
DRUGRanibizumab 0.5 MG/0.05 ML Intraocular Solution
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
Sponsors
Hospital Hietzing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 \[i.e. age-related macular degeneration (AMD) and associated choroidal neovascularization (CNV), cystoid macular edema (CME) of other origin (e.g. uveitis, Irvine-Gass syndrome, retinal vein occlusion), or retinal dystrophies\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 1 year | Functional alterations will be followed during treatment phase, essential for verification of treatment success. Units: Snellen equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Austria
Outcome results
None listed