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

Conditions

• Diabetic Retinal Edema

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Ranibizumab 0.5 MG/0.05 ML Intraocular Solution — 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

Study Details

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.

Key Dates

First listed

Jul 18, 2018

Start date

Apr 2, 2017

Status verified

Jul 2018

Primary completion

Apr 2, 2018

Completion

Jun 2, 2018

Study Design

Enrollment

50 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 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 \[Ranibizumab (Ranibizumab 0.5 MG/0.05 ML Intraocular Solution\]
• Active Comparator: 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 \[Ranibizumab 0.5 MG/0.05 ML Intraocular Solution\]

Primary Outcome Measure

Visual acuity [ Time Frame: 1 year ]