Efficacy of Retreatments With Intravitreal Bevacizumab | NCT00406744

Studies
Efficacy of Retreatments With Intravitreal Bevacizumab

NCT00406744

Sponsor

Asociación para Evitar la Ceguera en México

Status

Terminated

Last Update Posted

Jun 3, 2024Actual

Enrollment

20Actual

Phase

Phase 3

Conditions

Age Related Macular Degeneration
Choroidal Neovascularization

Interventions

Intravitreal injection of Bevacizumab

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

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Poor accrual

Expanded Access Info

Start Date

May 2006Actual

Primary Completion Date

May 2006Actual

Completion Date

Nov 2006Actual

First Submitted Date

Nov 30, 2006

First Submission Date that Met QC Criteria

Nov 30, 2006

First Posted Date

Dec 4, 2006Estimated

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

Description Module

Brief Summary

Choroidal neovascularization is a leading cause of visual loss in people older than 60 years and for its treatment there had been performed multicentric studies with Lucentis (Ranibizumab) with a significant improval of visual acuity. In our institution we evaluated efficacy of bevacizumab in several pathologies but we dont know what would be the results if we use the same dose several times. Our purpose was to determine the efficacy of bevacizumab for improve or stabilize visual acuity with two or more intravitreal inyections of bevacizumab.

Detailed Description

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Name	Type	Description	Arm Group Labels	Other Names
Intravitreal injection of Bevacizumab	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best corrected visual acuity, OCT foveal thickness and fluorescein angiogram

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

* Any visual acuity
- OCT: Central foveal thickness greater than 300 u or with evidence of subretinal fluid.
- Active angiogram leakage

Exclusion Criteria:

* Basal Inflammatory disease
- Endoftalmitis history
- Lesions bigger than 5400 u or with scarring greater than 50% of lesion.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

95 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
Veronica Kon-Jara, MD	Asociación para Evitar la Ceguera en México	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration
D020256	Choroidal Neovascularization
D009389	Neovascularization, Pathologic

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D015862	Choroid Diseases

Browse Leaves

Not provided

Browse Branches

Not provided