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Clinical Trials/EUCTR2012-003943-32-DE
EUCTR2012-003943-32-DE
Active, not recruiting
Phase 1

Influence of diabetes control on treatment of diabetic macular edema with ranibizumab

Charité University Medicine Berlin0 sites120 target enrollmentMarch 31, 2015
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DrugsLucentis

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Charité University Medicine Berlin
Enrollment
120
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 31, 2015
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\-Patients with diabetic macular edema relevant to visual acuity
  • •\-OCT retinal thickness \>\= 250µm
  • •\-HbA1c \> 6,5% at initial visit
  • •\-BCVA \<\= 0\.8 and \>\= 0,05
  • •\-Age \>\= 18 years
  • •\-Written informed consent given
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 80

Exclusion Criteria

  • •\-Previous treatment with intravitreal drugs in last 6 months
  • •\-Vitreous hemorrhage as a consequence of proliferative retinopathy which would hamper adequate diagnosis and imaging
  • •\-Blood pressure of \>\= 180/100 (or uncontrolled pressures under pharmacological therapy)
  • •\-Chronic systemic or ocular inflammatory/autoimmune diseases (e.g. inflammatory bowel disease, Addison´s disease, Cushing Syndrome, Uveitis)
  • •\-Systemic cortisone or anti\-VEGF therapy
  • •\-Acute systemic or ocular infectious diseases
  • •\-Prior laser photocoagulation treatment within 3 months (focal / grid laser or panretinal) prior to study entry
  • •\-Current treatment with pharmaceutical preparations with which interactions can be expected
  • •\-Persons who have a fluorescein allergy
  • •\-Women who are pregnant or breast feeding

Outcomes

Primary Outcomes

Not specified

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