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

Sponsor
Centro de Pesquisa Rubens Siqueira (Other)
Overall Status
Completed
CT.gov ID
NCT01662518
Collaborator
University of Sao Paulo (Other)
10
Enrollment
1
Location
1
Arm
59
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Dexamethasone drug delivery system (DDS-25)
 Phase 1/Phase 2

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
Actual Enrollment :
10 participants
Allocation:
N/A
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.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)
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)
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Best Corrected Visual Acuity (BCVA) [Day 0 - Day 180]

Secondary Outcome Measures

  1. Change in central foveal thickness at 48 weeks [1 day to 48 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Rubens Camargo Siqueira, MD,PhD - Principal Investigator, Centro de Pesquisa Rubens Siqueira
ClinicalTrials.gov Identifier:
NCT01662518
Other Study ID Numbers:
  • Bramets-01
First Posted:
Aug 10, 2012
Last Update Posted:
Feb 1, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Edema
Dexamethasone

Study Results

No Results Posted as of Feb 1, 2017