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OpenTrials
Completed

NCT Number: NCT01478737

Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

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).

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Key information

Conditions

Proliferative Diabetic Retinopathy Eye Diseases Eye Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Vitreous Hemorrhage

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Erik Eye Hospital

Stockholm, NonUS, 11282, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with vitreous hemorrhage undergoing PPV for PDRP

Exclusion criteria

  • Previous PPV
  • Vitreous hemorrhage of non-PDRP origin

Treatment and study plan

Intravitreal dexamethasone implant

Drug

Intravitreal Ozurdex after vitrectomy

Other names: OZURDEX® (dexamethasone intravitreal implant)

Vitrectomy

Procedure

Vitrectomy only

Primary outcomes

  1. Reoperation

    Time frame: 12 months

    The proportion of patients that, due to re-bleeding within 12 months, have a second PPV

Secondary outcomes

  1. Rebleeding

    Time frame: 12 months

    The number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously

Sponsors and collaborators

Lead sponsor

Anders Kvanta

Other

Registry information

Official study title

A Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 23, 2011
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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