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Clinical Trials/EUCTR2013-005056-15-BE
EUCTR2013-005056-15-BE
Active, not recruiting
Phase 1

ongterm efficiency and safety of intravitreal injections with bevacizumab in patients with neovascularisation or macular edema.

Z Gent0 sites800 target enrollmentFebruary 20, 2014
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ConditionsChoroidal neovascularisation and chronic macular edemaMedDRA version: 20.0Level: LLTClassification code 10054467Term: Macular edemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 21.1Level: PTClassification code 10060823Term: Choroidal neovascularisationSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
DrugsAvastin

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Choroidal neovascularisation and chronic macular edema
Sponsor
Z Gent
Enrollment
800
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 20, 2014
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Z Gent

Eligibility Criteria

Inclusion Criteria

  • •1\.Age \= 18 years of either gender
  • •2\.Written informed consent must be obtained before any intravitreal injection of bevacizumab is performed
  • •3\.Visual impairment predominantly due to abnormal new vessel ingrowth and/or macular edema. The prescence of fluid (intraretinal, subretinal or sub\-RPE) detected clinically or on the OCT.
  • •If both eyes are eligible for the study, both eyes can be included in the study
  • •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 400
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 400

Exclusion Criteria

  • •1\.Women who are pregnant or breastfeeding (pregnancy defined as the state of a female after conception until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5mIU/mL)
  • •Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 28 days following the last dose of study medication
  • •2\.Tromboembolic event (CVA or TIA, AMI) less than 3 months prior to the intravitreal injection of bevacizumab
  • •3\.History of hypersensitivity for bevacizumab.

Outcomes

Primary Outcomes

Not specified

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