Bevacizumab and Photodynamic Therapy in Neovascular Age R... | NCT00347399

Studies
Bevacizumab and Photodynamic Therapy in Neovascular Age Related Macular Degeneration

NCT00347399

Sponsor

Asociación para Evitar la Ceguera en México

Status

Terminated

Last Update Posted

May 30, 2024Actual

Enrollment

25Actual

Phase

Phase 2

Conditions

Age Related Macular Degeneration

Interventions

bevacizumab intravitreal injection
verteporfin photodynamic therapy

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

undefined

Expanded Access Info

Start Date

Mar 2006Actual

Primary Completion Date

Jun 30, 2006Actual

Completion Date

Jun 30, 2007Actual

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Jun 30, 2006

First Posted Date

Jul 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 29, 2024

Last Update Posted Date

May 30, 2024Actual

Description Module

Brief Summary

The purpose of this study is to determine if of combination therapy of intravitreal bevacizumab 4 days after the application of photodynamic therapy could improve the visual outcomes of patients with neovascular age related macular degeneration.

Detailed Description

The neovascular age related macular degeneration(AMD) is a important cause of legal blindness in adults older than 50 years. Currently the treatment is photodynamic therapy that offer stabilization and limited visual improvement after 2 years of therapy. Bevacizumab has been reported effective used as intravenous injection for AMD. But serious side effects have been reported with the use of this drug in oncologic patients. The intravitreal use has been reported in limited case reports and safety and efficacy should be determined. The purpose of this study is efficacy and safety of 2.5 mg intravitreal of bevacizumab for AMD 4 days after photodynamic therapy with verteporfin

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity improvement at 6 months	undefined	undefined

Secondary Outcomes

Measure	Description	Time Frame
Retinal thickness improvement at 6 months	undefined	undefined

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

55 years old neovascular Age related acular degeneration subfoveolar neovascular membrane best corrected visual acuity better than 20/200 snellen (1.0 logMAR)

Exclusion Criteria:

Previously treated eyes glaucoma diabetes mellitus uncontrolled hypertension coronary artery disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

99 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
Hugo Quiroz-Mercado, MD	Asociación para Evitar la Ceguera en México	Study Director
Jose Dalma Weizhaus, MD	Asociación para Evitar la Ceguera en México	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Luis Sanchez Bulnes		Mexico City	Mexico City	04030	Mexico

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16156152	Background	Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):331-5.

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

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

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab intravitreal injection	Drug
verteporfin photodynamic therapy	Procedure