NCT00571142

Brief Summary

To Evaluate combined effect of vitrectomy and bevacizumab to stabilize retinal thickness and visual acuity in patients with diffuse diabetic macular edema and their relation to renal disease.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

December 7, 2007

Last Update Submit

May 29, 2024

Conditions

Diffuse Diabetic Macular Edema

Keywords

edemaretinal thicknessdiabetic retinopathy

Outcome Measures

Primary Outcomes (1)

  • Retinal thickness

    3 months

Secondary Outcomes (1)

  • Visual acuity

    3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Renal disease

Procedure: Bevacizumab + Pars plana vitrectomy

2

ACTIVE COMPARATOR

Without renal disease

Procedure: Bevacizumab + pars plana vitrectomy

Interventions

Bevacizumab + pars plana vitrectomyPROCEDURE

2.5 mg / 0.1 ml bevacizumab after pars plana vitrectomy. Limitorexis would be optional.

1

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Older than 25 yo
  • Diffuse diabetic macular edema with or without previous treatment

You may not qualify if:

  • Another retinal disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociacion para Evitar la Ceguera en Mexico I.A.P.

México, 04030, Mexico

Location

MeSH Terms

Conditions

EdemaDiabetic Retinopathy

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Veronica Kon-Jara, MD

    Asociación para Evitar la Ceguera en México

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 11, 2007

Study Start

November 1, 2007

Primary Completion

November 1, 2007

Study Completion

February 1, 2008

Last Updated

May 31, 2024

Record last verified: 2024-05

Locations

ME(1)