DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
DDS-25
A Safety and Efficacy Study to Assess DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2011
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 8, 2012
CompletedFirst Posted
Study publicly available on registry
August 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFebruary 1, 2017
January 1, 2017
4.5 years
August 8, 2012
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual Acuity (BCVA)
Day 0 - Day 180
Secondary Outcomes (1)
Change in central foveal thickness at 48 weeks
1 day to 48 weeks
Study Arms (1)
DDS-25
EXPERIMENTALIntravitreal injection of DDS-25(Dexamethasone drug delivery system )
Interventions
350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centro de Pesquisa Rubens Siqueiralead
- University of Sao Paulocollaborator
Study Sites (1)
Centro de Pesquisa Rubens Siqueira
São José do Rio Preto, São Paulo, 15010-100, Brazil
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rubens C Siqueira, MD,PhD
Centro de Pesquisa Rubens Siqueira
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,PhD - Principal Investigator
Study Record Dates
First Submitted
August 8, 2012
First Posted
August 10, 2012
Study Start
July 1, 2011
Primary Completion
January 1, 2016
Study Completion
June 1, 2016
Last Updated
February 1, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
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.