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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centro de Pesquisa Rubens Siqueira
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Rubens Camargo Siqueira, Centro de Pesquisa Rubens Siqueira
ClinicalTrials.gov Identifier:
NCT01662518
First received: August 8, 2012
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662518

Contacts
Contact: Rubens C Siqueira, MD,PhD 55(17)32140896 rubenssiqueira@terra.com.br
Contact: Rubens C Siqueira, MD,PhD 55(17)32345858 rubenssiqueira@terra.com.br

Locations
Brazil
Centro de Pesquisa Rubens Siqueira Recruiting
Sao Jose do Rio Preto, SP, Brazil, 15010-100
Contact: Rubens C Siqueira, MD,PhD    55(17)32345858    rubenssiqueira@terra.com.br   
Principal Investigator: Rubens C Siqueira, MD,PhD         
Sponsors and Collaborators
Centro de Pesquisa Rubens Siqueira
University of Sao Paulo
Investigators
Principal Investigator: Rubens C Siqueira, MD,PhD Centro de Pesquisa Rubens Siqueira
  More Information

No publications provided

Responsible Party: Rubens Camargo Siqueira, MD,PhD - Principal Investigator, Centro de Pesquisa Rubens Siqueira
ClinicalTrials.gov 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:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on July 24, 2014