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

August 8, 2012
July 22, 2014
July 2011
November 2014   (final data collection date for primary outcome measure)
Best Corrected Visual Acuity (BCVA) [ Time Frame: Day 0 - Day 180 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01662518 on ClinicalTrials.gov Archive Site
Change in central foveal thickness at 48 weeks [ Time Frame: 1 day to 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
A Safety and Efficacy Study to Assess 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.

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).

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Macular Edema
  • Retinal Vein Occlusion
Device: Dexamethasone drug delivery system (DDS-25)
350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline
Experimental: DDS-25
Intravitreal injection of DDS-25(Dexamethasone drug delivery system )
Intervention: Device: Dexamethasone drug delivery system (DDS-25)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
January 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Brazil
 
NCT01662518
Bramets-01
No
Rubens Camargo Siqueira, Centro de Pesquisa Rubens Siqueira
Centro de Pesquisa Rubens Siqueira
University of Sao Paulo
Principal Investigator: Rubens C Siqueira, MD,PhD Centro de Pesquisa Rubens Siqueira
Centro de Pesquisa Rubens Siqueira
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP