POSTERIOR SUB-TENON'S Avastin | NCT00567372

Studies
POSTERIOR SUB-TENON'S Avastin

NCT00567372

Sponsor

Asociación para Evitar la Ceguera en México

Status

Withdrawn

Last Update Posted

Jun 3, 2024Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Diffuse Diabetic Macular Edema

Interventions

bevacizumab (Sub-tenon´s injection)

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Poor accrual

Expanded Access Info

Start Date

Jun 2008Actual

Primary Completion Date

Nov 2008Actual

Completion Date

Jun 2009Actual

First Submitted Date

Nov 30, 2007

First Submission Date that Met QC Criteria

Dec 3, 2007

First Posted Date

Dec 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2024

Last Update Posted Date

Jun 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab (Sub-tenon´s injection)	Drug	a single posterior sub-tenon's capsule injection of bevacizumab (2.5 mg /0.1ml)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
macular volume		baseline, 3,6 and 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
macular thickness		baseline,3,6 and 12 weeks
best corrected visual acuity		baseline, 3,6 and 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with diffuse diabetic macular edema non-proliferative diabetic retinopathy Maculat thickness ≥250 μ BCVA ≥ 20/400 Without any treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sandra Vera, MD	Asociación para Evitar la Ceguera en Mexico	Principal Investigator
Hugo Quiroz-Mercado, MD	Denver Health Medical Center	Principal Investigator
Adai Pérez-Montesinos, MD	Asociación para Evitar la Ceguera en Mexico	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asociación para Evitar la Ceguera en Mexico		Mexico City	Mexico City	04030	Mexico

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided