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

Centro de Pesquisa Rubens Siqueira

Status and phase: Completed; Phase 2; Phase 1

Conditions: Macular Edema; Retinal Vein Occlusion

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01662518

Bramets-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

DDS-25

Experimental group

Description:

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

Treatment:

Device: Dexamethasone drug delivery system (DDS-25)