DDS-25 Gauge in Patients With Macular Edema Secondary to... | NCT01662518

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

NCT01662518

Sponsor

Centro de Pesquisa Rubens Siqueira

Status

Completed

Last Update Posted

Feb 1, 2017Estimated

Enrollment

10Actual

Phase

Phase 1Phase 2

Conditions

Macular Edema
Retinal Vein Occlusion

Interventions

Dexamethasone drug delivery system (DDS-25)

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jan 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Aug 8, 2012

First Submission Date that Met QC Criteria

Aug 9, 2012

First Posted Date

Aug 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2017

Last Update Posted Date

Feb 1, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rubens Camargo Siqueira, MD,PhD - Principal Investigator, Centro de Pesquisa Rubens SiqueiraPrincipal Investigator

Lead Sponsor

Centro de Pesquisa Rubens SiqueiraOTHER

Collaborators

Name	Class
University of Sao Paulo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DDS-25	Experimental	Intravitreal injection of DDS-25(Dexamethasone drug delivery system )	Device: Dexamethasone drug delivery system (DDS-25)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone drug delivery system (DDS-25)	Device	350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline	DDS-25

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best Corrected Visual Acuity (BCVA)		Day 0 - Day 180

Secondary Outcomes

Measure	Description	Time Frame
Change in central foveal thickness at 48 weeks		1 day to 48 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rubens C Siqueira, MD,PhD	Centro de Pesquisa Rubens Siqueira	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro de Pesquisa Rubens Siqueira		São José do Rio Preto	São Paulo	15010-100	Brazil

References Module

Citations

Not provided

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Term
D008269	Macular Edema
D012170	Retinal Vein Occlusion