Dexamethasone-implant for the Treatment of RVO

NCT ID: NCT01767545

Last Updated: 2013-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Edema Caused by Retinal Vein Occlusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexamethasone-implant (Group 1)

Group 1 included 38 patients (22 with CRVO and 16 with BRVO) and was treated with a dexamethasone-implant injection from the beginning.

Group Type ACTIVE_COMPARATOR

Dexamethasone implant

Intervention Type DRUG

Bevacizumab/Dexamethasone-implant (Group 2)

Group 2 included 26 patients (14 CRVO, 12 BRVO) and was treated with three consecutive injections of bevacizumab at a monthly interval, followed by a dexamethasone-implant injection four weeks after the last bevacizumab injection.

Group Type ACTIVE_COMPARATOR

Dexamethasone implant

Intervention Type DRUG

Bevacizumab

Intervention Type DRUG

Interventions

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Dexamethasone implant

Intervention Type DRUG

Bevacizumab

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Wolfgang Mayer

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept. of Ophthalmology, LMU Munich

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Mayer-DEX-001

Identifier Type: -

Identifier Source: org_study_id

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