Intravitreal Bevacizumab and Low Fluence Photodynamic The... | NCT00802126

Studies
Intravitreal Bevacizumab and Low Fluence Photodynamic Therapy

NCT00802126

Sponsor

University of Campania Luigi Vanvitelli

Status

Completed

Last Update Posted

Feb 8, 2016Estimated

Enrollment

16Actual

Phase

Phase 1

Conditions

Myopia

Interventions

Combination therapy "IVB + rf-PDT"

Countries

Italy

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

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Dec 2008Actual

Completion Date

May 2009Actual

First Submitted Date

Dec 2, 2008

First Submission Date that Met QC Criteria

Dec 3, 2008

First Posted Date

Dec 4, 2008Estimated

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

Feb 5, 2016

Last Update Posted Date

Feb 8, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chiosi Flavia, Chiosi Flavia, University of Campania Luigi VanvitelliPrincipal Investigator

Lead Sponsor

University of Campania Luigi VanvitelliOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Description Module

Brief Summary

The purpose of this study is to report the treatment effect and safety of combined intravitreal bevacizumab (IVB) and photodynamic therapy (PDT) with verteporfin using a reduced (RF) light fluence rate, in choroidal neovascularization (CNV) secondary to pathologic myopia.

Detailed Description

In this retrospective interventional case series, 16 patients with myopic CNV were included. All patients were treated with 1.25 mg of intravitreal bevacizumab followed by RF-PDT (25 J/cm²), 2 days later. All patients were previously treated with IVB monotherapy and active leaking of CNV occurred 90 to 120 days after the treatment.

Best-corrected visual acuity (BCVA-ETDRS), foveal thickness (FT) on optical coherence tomography (OCT), and fluorescein and indocyanine green angiographic (FA; ICG) findings were recorded. Follow-up evaluations were carried out for 12 months.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bevacizumab and verteporfin	Experimental		Drug: Combination therapy "IVB + rf-PDT"

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Combination therapy "IVB + rf-PDT"	Drug	low-fluence photodynamic therapy combined with intravitreal bevacizumab	Bevacizumab and verteporfin

Measure	Description	Time Frame
BCVA improved		6 months

Measure	Description	Time Frame
no CNV leakage		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Myopic CNV, CNV leakage

Exclusion Criteria:

CNV not associated with high myopia
No activity of CNV

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michele Rinaldi, MD, PhD	University of Campania Luigi Vanvitelli	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmology Department SUN		Naples	Napoli	80100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided