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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Diabetic Macular Edema (DME) With Intravitreal Anti-vascular Endothelial Growth Factor (Anti-VEGF) and Prompt Versus Deferred Focal Laser During Long-term Follow-up and Identification of Prognostic Retinal Markers

Conditions
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Diabetic Retinal Edema

Intervention / Treatment
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* Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution


Participation Criteria
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Eligibility Criteria
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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]
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prompt laser group<br>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] | Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution<br>* 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<br>* Other names: Focal grid laser;|
| Active Comparator: Deferred laser group<br>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] | Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution<br>* 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<br>* Other names: Focal grid laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Functional alterations will be followed during treatment phase, essential for verification of treatment success. Units: Snellen equivalents | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 year | 
| Central retinal thickness | Morphological alterations will be followed during treatment phase, essential for verification of treatment success. Units: Micrometer (retinal thickness) | 1 year |