NCT01767545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2013

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

4 months

First QC Date

January 9, 2013

Last Update Submit

January 10, 2013

Conditions

Macular Edema Caused by Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (3)

  • Central retinal thickness

    12 months

  • Lens opacity

    12 months

  • Saftey of procedure

    12 months

Study Arms (2)

Dexamethasone-implant (Group 1)

ACTIVE COMPARATOR

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

Drug: Dexamethasone implant

Bevacizumab/Dexamethasone-implant (Group 2)

ACTIVE COMPARATOR

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.

Drug: Dexamethasone implantDrug: Bevacizumab

Interventions

Dexamethasone implantDRUG
Bevacizumab/Dexamethasone-implant (Group 2)Dexamethasone-implant (Group 1)
BevacizumabDRUG
Bevacizumab/Dexamethasone-implant (Group 2)

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Ophthalmology, LMU Munich

Munich, 80336, Germany

Location

MeSH Terms

Interventions

DexamethasoneBevacizumab

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 14, 2013

Study Start

September 1, 2010

Primary Completion

January 1, 2011

Study Completion

February 1, 2012

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

DE(1)