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

NCT01112085 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-06-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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)

DRUG

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)

Sponsors & Collaborators

  • Centro de Retina Medica y Quirurgica S.C.

    collaborator OTHER

  • Especialistas en Retina Medica y Quirurgica Grupo de Investigacion

    lead NETWORK

Principal Investigators

  • Arturo Santos, MD PhD · Centro de Retina Médica y Quirúrgica S. C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-01-31
Completion
2014-06-30

Countries

  • Argentina
  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01112085 on ClinicalTrials.gov