Dexamethasone-implant for the Treatment of RVO

Ludwig-Maximilians - University of Munich64 enrolled

Overview

To evaluate the efficacy and safety of a dexamethasone-implant alone or in combination with bevacizumab. 64 eyes are prospectively investigated. Group 1 (22 CRVO and 16 BRVO) is treated with dexamethasone-implant alone, Group 2 (14 CRVO 12 BRVO) with three consecutive bevacizumab injections followed by a dexamethasone-implant. Recurrences are treated with dexamethasone-implant only. Patients are seen preoperatively and thereafter in monthly intervals. The primary endpoint was BCVA at twelve months.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Macular Edema Caused by Retinal Vein Occlusion

Interventions

Dexamethasone implantDRUG

BevacizumabDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: maximum duration of symptoms of four months and no known history of glaucoma or corticosteroid response in the past - Exclusion Criteria: Glaucoma, Diabetic Retinopathy, prior IVOM, Uveitis \-

Locations (1)

Dept. of Ophthalmology, LMU Munich

Munich, Germany

Outcomes

Primary Outcomes

The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment.

Time frame: 12 months

Secondary Outcomes

Central retinal thickness

Time frame: 12 months

Lens opacity

Time frame: 12 months

Saftey of procedure

Time frame: 12 months

Data from ClinicalTrials.gov

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