NCT00571142

TerminatedPhase 3

Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edem...

Asociación para Evitar la Ceguera en México Source

Asociación para Evitar la Ceguera en México

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

APEC-ret

Study Type

interventional

Actual enrollment (reported)

20

Locations

1 country

Sites

1

Timeline

Study Start

November 2007

Actual (reported)

Primary Completion

November 2007

Actual (reported)

Study Completion

February 2008

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 20 participants
Study completion date: February 2008
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2007
Actual (reported)
Primary Completion
November 2007
Actual (reported)
First Submitted
December 7, 2007
Actual (reported)
First Posted
December 11, 2007
Actual (reported)
Study Completion
February 2008
Actual (reported)

Last Updated: May 31, 2024
Status Verified: May 2024
Last Update Submitted: 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

Bevacizumab + pars plana vitrectomyProcedure

2.5 mg /0.1 ml of bevacizumab after pars plana vitrectomy

2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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:

Sponsors & Collaborators

Asociación para Evitar la Ceguera en México
Otherlead

Study Sites (1)

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

México, 04030, Mexico

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)

Study Officials

Veronica Kon-Jara, MD
Asociación para Evitar la Ceguera en México
PRINCIPAL INVESTIGATOR

Enrollment

20 participants (actual enrollment reported by the registry).

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 2007

Actual (reported)

Primary Completion

NCT00886808

Safety Study of iCo-007 Intravitreal Injection to Treat Diabetic Macular Edema

Phase 1Completed

Another retinal disease
Pregnancy

Contact the study team to confirm eligibility.

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

November 2007

Actual (reported)

Study Completion

February 2008

Actual (reported)

Last Updated

May 31, 2024

Record last verified: 2024-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00571142
Data provider: ClinicalTrials.gov
Source updated: 2024-05-31
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:18 UTC

Locations

MX(1)

Study Stopped

Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations