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Influence of the Vitreomacular Interface on the Progression of the Diabetic Macular Edema After Anti-VEGF Injection

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ClinicalTrials.gov Identifier: NCT02933905
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Xavier Valldeperas, Fundació Institut Germans Trias i Pujol

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Influence of the vitreomacular interface on the progression of diabetic macular edema after treatment with intravitreal injection of vascular endothelial growth factor inhibitors

Condition or disease Intervention/treatment
Diabetic Macular Edema Vitreomacular Interface Anti-VEGF Treatment Drug: Intravitreal Ranibizumab injection

Study Design
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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Non-PVD subjects
Patients with no PVD on SD-OCT at basal visit
 Drug: Intravitreal Ranibizumab injection
PVD subjects
Patients with PVD on SD-OCT at basal visit
 Drug: Intravitreal Ranibizumab injection


Outcome Measures
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Primary Outcome Measures :
  1. Change in best-corrected visual acuity [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Change in central macular thickness [ Time Frame: One year ]
  2. Number of ranibizumab injections [ Time Frame: One year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with diabetic macular edema
Criteria

Inclusion Criteria:

  • diabetic macular edema treatable with antiangiogenic drugs

Exclusion Criteria:

  • age under 18
  • cardiovascular events during the last year
  • previous vitrectomy
  • previous macular edema treatment during the last 4 months
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Xavier Valldeperas, MD, PhD, FEBO, Fundació Institut Germans Trias i Pujol
ClinicalTrials.gov Identifier: NCT02933905    
Other Study ID Numbers: OFT-RAN-2013-01
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents