Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01662518
NCT01662518CompletedPhase 1

A Safety and Efficacy Study to Assess DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Centro de Pesquisa Rubens Siqueira1 site in 1 country10 target enrollmentStarted: July 1, 2011Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
10
Locations
1
Primary Endpoint
Best Corrected Visual Acuity (BCVA)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

DDS-25

Experimental

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

Intervention: Dexamethasone drug delivery system (DDS-25) (Device)

Outcomes

Primary Outcomes

Best Corrected Visual Acuity (BCVA)

Time Frame: Day 0 - Day 180

Secondary Outcomes

  • Change in central foveal thickness at 48 weeks(1 day to 48 weeks)

Investigators

Sponsor
Centro de Pesquisa Rubens Siqueira
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rubens Camargo Siqueira

MD,PhD - Principal Investigator

Centro de Pesquisa Rubens Siqueira

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 3
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular EdemaDiabetic Macular Edema
NCT00168337Allergan554
Completed
Phase 3
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein OcclusionRetinal Vein OcclusionMacular Edema
NCT00168298Allergan668
Terminated
Phase 2
A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Anterior UveitisAnterior Uveitis
NCT00333996Allergan5
Completed
Phase 3
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular EdemaDiabetic Macular Edema
NCT00168389Allergan494
Completed
Phase 3
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein OcclusionMacular EdemaRetinal Vein Occlusion
NCT00168324Allergan599