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

Primary Purpose

Macular Edema, Retinal Vein Occlusion

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Dexamethasone drug delivery system (DDS-25)
Sponsored by
Centro de Pesquisa Rubens Siqueira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Pesquisa Rubens Siqueira

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DDS-25

Arm Description

Intravitreal injection of DDS-25(Dexamethasone drug delivery system )

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity (BCVA)

Secondary Outcome Measures

Change in central foveal thickness at 48 weeks

Full Information

First Posted
August 8, 2012
Last Updated
January 30, 2017
Sponsor
Centro de Pesquisa Rubens Siqueira
Collaborators
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01662518
Brief Title
DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
Acronym
DDS-25
Official Title
A Safety and Efficacy Study to Assess DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro de Pesquisa Rubens Siqueira
Collaborators
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Retinal Vein Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
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
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DDS-25
Arm Type
Experimental
Arm Description
Intravitreal injection of DDS-25(Dexamethasone drug delivery system )
Intervention Type
Device
Intervention Name(s)
Dexamethasone drug delivery system (DDS-25)
Intervention Description
350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity (BCVA)
Time Frame
Day 0 - Day 180
Secondary Outcome Measure Information:
Title
Change in central foveal thickness at 48 weeks
Time Frame
1 day to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens C Siqueira, MD,PhD
Organizational Affiliation
Centro de Pesquisa Rubens Siqueira
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Pesquisa Rubens Siqueira
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15010-100
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/27632583
Description
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.

Learn more about this trial

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

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