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

This study has been completed.
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: January 30, 2017
Last verified: January 2017

August 8, 2012
January 30, 2017
July 2011
January 2016   (Final data collection date for primary outcome measure)
Best Corrected Visual Acuity (BCVA) [ Time Frame: Day 0 - Day 180 ]
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 ]
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
Intervention Model Description:
intervention group: 25-gauge biodegradable implant containing 350 μg of dexamethasone (DDS-25) for the treatment of decreased vision due to macular edema associated with central or branch retinal vein occlusion.
Masking: No masking
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.
 
Completed
10
June 2016
January 2016   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01662518
Bramets-01
No
Not Provided
Yes

Retin Cases Brief Rep. 2016 Sep 14. [Epub ahead of print] SAFETY AND FEASIBILITY OF A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT OF DEXAMETHASONE FOR TREATMENT OF MACULAR EDEMA ASSOCIATED WITH RETINAL VEIN OCCLUSION: A PHASE I CLINICAL TRIAL.

Cunha RB1, Siqueira RC, Messias A, Scott IU, Fialho SL, Cunha-Junior AD, Jorge R.

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
January 2017

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