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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
  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
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
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 ]

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

Enrollment: 10
Study Start Date: July 2011
Study Completion Date: June 2016
Primary Completion Date: January 2016 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Brazil
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
Investigators
Principal Investigator: Rubens C Siqueira, MD,PhD Centro de Pesquisa Rubens Siqueira
  More Information

Additional Information:
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: January 30, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description:

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.


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

ClinicalTrials.gov processed this record on February 24, 2017