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Completed

NCT Number: NCT01662518

DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone (DDS-25) for the treatment of macular edema associated with retinal vein occlusion.

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Key information

Conditions

Macular Edema Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centro de Pesquisa Rubens Siqueira

São José do Rio Preto, São Paulo, 15010-100, Brazil

About this study

Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 10 patients with macular edema associated with retinal vein occlusion undergoing intravitreal injection of implant of dexamethasone (DDS-25).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older with macular edema resulting from retinal vein occlusion
  • Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
  • Visual acuity in other eye no worse than 20/200

Exclusion criteria

  • Known anticipated need for ocular surgery within next 12 months
  • History of glaucoma or current high eye pressure requiring more than 1 medication
  • Diabetic retinopathy
  • Uncontrolled systemic disease
  • Known steroid-responder
  • Use of systemic steroids
  • Use of warfarin/heparin

Treatment and study plan

Dexamethasone drug delivery system (DDS-25)

Device

350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline

Primary outcomes

  1. Best Corrected Visual Acuity (BCVA)

    Time frame: Day 0 - Day 180

Secondary outcomes

  1. Change in central foveal thickness at 48 weeks

    Time frame: 1 day to 48 weeks

Sponsors and collaborators

Lead sponsor

Centro de Pesquisa Rubens Siqueira

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study title

A Safety and Efficacy Study to Assess DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Acronym: DDS-25

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 10, 2012
Registry last updated
Feb 1, 2017

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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