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NCT01662518 Clinical Trial

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

Macular Edema Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01662518
Other study ID # Bramets-01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 8, 2012
Last updated January 30, 2017
Start date July 2011
Est. completion date June 2016

Study information
Verified date January 2017
Source Centro de Pesquisa Rubens Siqueira
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date June 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Dexamethasone drug delivery system (DDS-25)
350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline

Locations
Country Name City State
Brazil Centro de Pesquisa Rubens Siqueira Sao Jose do Rio Preto SP

Sponsors (2)
Lead Sponsor Collaborator
Centro de Pesquisa Rubens Siqueira University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Best Corrected Visual Acuity (BCVA) Day 0 - Day 180
Secondary Change in central foveal thickness at 48 weeks 1 day to 48 weeks
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