Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02140411
Phase
PHASE4
Status
Completed

Conditions

  • Age Related Macular Degeneration
  • Retinal Vein Occlusion

Eligibility Criteria

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

Interventions

Study Details

Ranibizumab is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody fragment approved in Chile by the Instituto de Salud Pública for the treatment of diabetic macular edema (DME), retinal vein occlusion and age-related macular degeneration. Currently, there is limited epidemiologic information in Chile regarding the incidence of DME and limited experience of anti-VEGF hospital therapy. This study will evaluate the efficacy of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical and functional improvement following this treatment and to increase the local experience regarding the use of anti-VEGF in the treatment of diabetic macular edema.

Key Dates

First listed
May 16, 2014
Start date
Apr 25, 2015
Status verified
Oct 2018
Primary completion
Dec 21, 2016
Completion
Dec 21, 2016

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab
    Ranibizumab treatment

Primary Outcome Measure

Mean Change From Baseline in Best Correct Visual Acuity (BCVA) [ Time Frame: baseline, week 48 ]

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