Macular Edema, Retinal Vein Occlusion
Conditions
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).
Interventions
DEVICEDexamethasone drug delivery system (DDS-25)
350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline
Sponsors
University of Sao Paulo
Centro de Pesquisa Rubens Siqueira
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity (BCVA) | Day 0 - Day 180 |
Secondary
| Measure | Time frame |
|---|---|
| Change in central foveal thickness at 48 weeks | 1 day to 48 weeks |
Countries
Brazil
Outcome results
None listed