Combination of Standard Lucentis Therapy With Micropulse Diode Laser for the Treatment of Diabetic Macular Edema

Sponsor
GWT-TUD GmbH
Study ID
NCT02059772
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ranibizumab — DRUG
  • micropulse diode laser — PROCEDURE

Study Details

The primary objective of this study is to evaluate if a combination therapy with micropulse diode laser treatment shows non inferiority on visual acuity within 12 months in comparison to standard therapy (intravitreal injection of ranibizumab only).

Key Dates

First listed
Feb 11, 2014
Start date
Apr 30, 2014
Status verified
Feb 2017
Primary completion
Nov 30, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Control Group
    Standard therapy of diabetic macular edema with Lucentis (ranibizumab) according to SmPC
  • Experimental: Treatment Group
    Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment

Primary Outcome Measure

change in best corrected visual acuity (BCVA) [ Time Frame: baseline, 12 month ]

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