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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02933905
Other study ID # OFT-RAN-2013-01
Secondary ID
Status Completed
Phase N/A
First received October 12, 2016
Last updated October 14, 2016
Start date January 2014
Est. completion date June 2016

Study information

Verified date October 2016
Source Fundació Institut Germans Trias i Pujol
Contact n/a
Is FDA regulated No
Health authority Institut Català de la Salut. Barcelona, Spain:
Study type Observational

Clinical Trial Summary

Influence of the vitreomacular interface on the progression of diabetic macular edema after treatment with intravitreal injection of vascular endothelial growth factor inhibitors


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date June 2016
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Drug:
Intravitreal Ranibizumab injection


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fundació Institut Germans Trias i Pujol

Outcome

Type Measure Description Time frame Safety issue
Primary Change in best-corrected visual acuity One year No
Secondary Change in central macular thickness One year No
Secondary Number of ranibizumab injections One year No
See also
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Terminated NCT04603937 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Terminated NCT04611152 - A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Active, not recruiting NCT04108156 - This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab Phase 3
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