NCT00806169

Brief Summary

The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic retinopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2006

Typical duration for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

2.5 years

First QC Date

December 4, 2008

Last Update Submit

September 26, 2012

Conditions

Macular EdemaDiabetic Retinopathy

Keywords

combined therapyDRPefficacysafetysustainabilitymacular edema due to DRP

Outcome Measures

Primary Outcomes (1)

  • Best Corrected Visual Acuity

    Day of exam

Study Arms (3)

1

EXPERIMENTAL

group I (n=17) nonproliferative DR and ischemic maculopathy

Drug: triamcinolone and bevacizumab

2

EXPERIMENTAL

group II (n=38) nonproliferative DR without ischemic maculopathy

Drug: triamcinolone and bevacizumab

3

EXPERIMENTAL

group III (n=18) proliferative DR with or without ischemic maculopathy

Drug: triamcinolone and bevacizumab

Interventions

triamcinolone and bevacizumabDRUG
123

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of diabetic retinopathy
  • macular edema more than 200 micron
  • vitreous bleeding because of angiography documented NVEs NVDs, based on the definitions of ETDRS

You may not qualify if:

  • Prior intraocular injection within 4 months
  • Core or complete vitrectomy
  • History of glaucoma or ocular hypertension
  • Presence of iris neovascularization
  • Significant media opacity
  • Monocularity and pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Vitreoretinal Surgery

Frankfurt am Main, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Macular EdemaDiabetic Retinopathy

Interventions

TriamcinoloneBevacizumab

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 10, 2008

Study Start

April 1, 2006

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

DE(1)