MIcrodoses of raNIbizumab in Diabetic MAcular Edema (MINIMA-2)

Sponsor
Especialistas en Retina Medica y Quirurgica Grupo de Investigacion
Study ID
NCT01112085
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab 0.05mg — DRUG
    Intravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria)
  • Ranibizumab 0.5mg — DRUG
    Intravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria)

Study Details

The objective of this study is to investigate if the drug ranibizumab administrated by microdose injection into the eye is safe and effective to treat diabetic macular edema.

Key Dates

First listed
Apr 28, 2010
Start date
Apr 30, 2010
Status verified
Jun 2014
Primary completion
Jan 31, 2014
Completion
Jun 30, 2014

Study Design

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

Arms

  • Experimental: Ranibizumab 0.05mg
    Intravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria)
  • Experimental: Ranibizumab 0.5mg
    Intravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria)

Primary Outcome Measure

Best corrected visual acuity [ Time Frame: 12 months ]

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