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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01478737
Other study ID # PDRPOZU1
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2011
Est. completion date April 2016

Study information

Verified date January 2024
Source St. Erik Eye Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous hemorrhage after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy (PDRP).


Description:

To perform a randomized, controlled, study on patients that undergo PPV for vitreous hemorrhage secondary to PDRP. Half of the patients will receive an intravitreal Ozurdex implant immediately after surgery. The primary outcome measure is the proportion of patients that, due to rebleeding within 12 months, have a second PPV. Secondary outcome measures include the number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Patients with vitreous hemorrhage undergoing PPV for PDRP Exclusion Criteria: - Previous PPV - Vitreous hemorrhage of non-PDRP origin

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Intravitreal dexamethasone implant
Intravitreal Ozurdex after vitrectomy
Procedure:
Vitrectomy
Vitrectomy only

Locations

Country Name City State
Sweden St. Erik Eye Hospital Stockholm NonUS

Sponsors (1)

Lead Sponsor Collaborator
Anders Kvanta

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reoperation The proportion of patients that, due to re-bleeding within 12 months, have a second PPV 12 months
Secondary Rebleeding The number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously 12 months
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