NCT00802126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

1.1 years

First QC Date

December 2, 2008

Last Update Submit

February 5, 2016

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • BCVA improved

    6 months

Secondary Outcomes (1)

  • no CNV leakage

    6 months

Study Arms (1)

Bevacizumab and verteporfin

EXPERIMENTAL
Drug: Combination therapy "IVB + rf-PDT"

Interventions

Combination therapy "IVB + rf-PDT"DRUG

low-fluence photodynamic therapy combined with intravitreal bevacizumab

Also known as: Combined therapy: IVB + rf-PDT
Bevacizumab and verteporfin

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Myopic CNV, CNV leakage

You may not qualify if:

  • CNV not associated with high myopia
  • No activity of CNV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Department SUN

Napoli, Napoli, 80100, Italy

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Michele Rinaldi, MD, PhD

    University of Campania Luigi Vanvitelli

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chiosi Flavia

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 4, 2008

Study Start

November 1, 2007

Primary Completion

December 1, 2008

Study Completion

May 1, 2009

Last Updated

February 8, 2016

Record last verified: 2016-02

Locations

IT(1)