NCT00406250

Brief Summary

The purpose of this study is to investigate the safety and efficacy of intravitreal bevacizumab in patients with choroidal neovascularization associated with angioid streaks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2006

Typical duration for phase_1

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, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 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

2.1 years

First QC Date

November 30, 2006

Last Update Submit

February 5, 2016

Conditions

Angioid StreaksChoroidal Neovascularization

Outcome Measures

Primary Outcomes (1)

  • BCVA improvement

    6 months

Secondary Outcomes (1)

  • reduction or cessation leakage

    6 months

Study Arms (1)

Bevacizumab

EXPERIMENTAL
Drug: intravitreal injection

Interventions

intravitreal injectionDRUG

1.25 mg in 0.05 cc of bevacizumab

Also known as: intravitreal bevacizumab
Bevacizumab

Eligibility Criteria

Age44 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of an active CNV
  • visual loss
  • increased retinal thickness

You may not qualify if:

  • no actively leaking CNV by FAG
  • normal retinal thickness
  • satisfactory visual acuity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dipartimento di Oftalmologia, SUN

Napoli, Napoli, 80100, Italy

Location

MeSH Terms

Conditions

Angioid StreaksChoroidal Neovascularization

Interventions

Intravitreal Injections

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Michele Rinaldi, MD

    University of Campania Luigi Vanvitelli

    PRINCIPAL INVESTIGATOR

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

November 30, 2006

First Posted

December 4, 2006

Study Start

November 1, 2006

Primary Completion

December 1, 2008

Study Completion

May 1, 2009

Last Updated

February 8, 2016

Record last verified: 2016-02

Locations

IT(1)