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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Centro de Pesquisa Rubens Siqueira.
Recruitment status was:  Recruiting
University of Sao Paulo
Information provided by (Responsible Party):
Rubens Camargo Siqueira, Centro de Pesquisa Rubens Siqueira Identifier:
First received: August 8, 2012
Last updated: July 22, 2014
Last verified: July 2014
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.

Condition Intervention Phase
Macular Edema
Retinal Vein Occlusion
Device: Dexamethasone drug delivery system (DDS-25)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study to Assess DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Resource links provided by NLM:

Further study details as provided by Centro de Pesquisa Rubens Siqueira:

Primary Outcome Measures:
  • Best Corrected Visual Acuity (BCVA) [ Time Frame: Day 0 - Day 180 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in central foveal thickness at 48 weeks [ Time Frame: 1 day to 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: July 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DDS-25
Intravitreal injection of DDS-25(Dexamethasone drug delivery system )
Device: Dexamethasone drug delivery system (DDS-25)
350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline

Detailed Description:
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).

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01662518

Centro de Pesquisa Rubens Siqueira
Sao Jose do Rio Preto, SP, Brazil, 15010-100
Sponsors and Collaborators
Centro de Pesquisa Rubens Siqueira
University of Sao Paulo
Principal Investigator: Rubens C Siqueira, MD,PhD Centro de Pesquisa Rubens Siqueira
  More Information

Responsible Party: Rubens Camargo Siqueira, MD,PhD - Principal Investigator, Centro de Pesquisa Rubens Siqueira Identifier: NCT01662518     History of Changes
Other Study ID Numbers: Bramets-01 
Study First Received: August 8, 2012
Last Updated: July 22, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors processed this record on January 17, 2017