Dexamethasone-implant for the Treatment of RVO

Twelve Months Experience With a Dexamethasone-implant for the Treatment of Macular Edema Associated With Retinal Vein Occlusion

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01767545

Enrollment

Registered

2013-01-14

Start date

2010-09-30

Completion date

2012-02-29

Last updated

2013-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema Caused by Retinal Vein Occlusion

Brief summary

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.

Interventions

DRUGDexamethasone implant

DRUGBevacizumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

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 \-

Design outcomes

Primary

Measure	Time frame
The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment.	12 months

Secondary

Measure	Time frame
Central retinal thickness	12 months
Lens opacity	12 months
Saftey of procedure	12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026