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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-02

Study Completion Date

2018-06-02

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.

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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.

Conditions

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Diabetic Retinal Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prompt laser group

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 \[Ranibizumab (Ranibizumab 0.5 MG/0.05 ML Intraocular Solution\]

Group Type ACTIVE_COMPARATOR

Ranibizumab 0.5 MG/0.05 ML Intraocular Solution

Intervention Type DRUG

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

Deferred laser group

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 \[Ranibizumab 0.5 MG/0.05 ML Intraocular Solution\]

Group Type ACTIVE_COMPARATOR

Ranibizumab 0.5 MG/0.05 ML Intraocular Solution

Intervention Type DRUG

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

Interventions

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Ranibizumab 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

Intervention Type DRUG

Other Intervention Names

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Focal grid laser

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No