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

Centro de Pesquisa Rubens Siqueira10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Macular Edema Retinal Vein Occlusion

Interventions

Dexamethasone drug delivery system (DDS-25)DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centro de Pesquisa Rubens Siqueira

São José do Rio Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

Best Corrected Visual Acuity (BCVA)

Time frame: Day 0 - Day 180

Secondary Outcomes

Change in central foveal thickness at 48 weeks

Time frame: 1 day to 48 weeks

Data from ClinicalTrials.gov

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