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Intravitreal Bevacizumab in Agioid Streaks

Primary Purpose

Angioid Streaks, Choroidal Neovascularization

Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
intravitreal injection
intravitreal injection
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angioid Streaks

Eligibility Criteria

44 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Dipartimento di Oftalmologia, SUN

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab

Arm Description

Outcomes

Primary Outcome Measures

BCVA improvement

Secondary Outcome Measures

reduction or cessation leakage

Full Information

First Posted
November 30, 2006
Last Updated
February 5, 2016
Sponsor
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT00406250
Brief Title
Intravitreal Bevacizumab in Agioid Streaks
Official Title
Intravitreal Bevacizumab for Choroidal Neovascularization Secondary to Angioid Streaks: 24 Months Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
To investigate the safety and efficacy of intravitreal bevacizumab in a patient with choroidal neovascularization associated with angioid streaks. One of the most serious ocular complication of angioid streaks is the occurrence of choroidal neovascularization (CNV) and because of the implication of the macula, this complication usually leads to central vision loss. During the past, laser photocoagulation, first, and photodynamic therapy (PDT), more recently, have been used as treatment for this kind of CNV. The outcome of these therapies was often variable and sometimes disappointing for the stabilization of visual acuity and lesion size in CNV secondary to AS. Five patients (six eyes) with CNV secondary to AS participated in this retrospective interventional case series. All patients were scheduled for three monthly IVB injections (1.25 mg). Two eyes had been previously treated with photodynamic therapy (PDT), and four received IVB as first choice treatment. IVB was repeated in case of recurrence after the three monthly IVB schedule. Ophthalmic evaluations included: best corrected visual acuity (BCVA) determination (ETDRS), optical coherence tomography (OCT), fluorescein and indocyanine green angiographies. Main outcome measures were BCVA improvement, reduction of leakage from CNV and diminution of central retinal thickness (CRT). Patients were followed-up for 30 months. Patients were 3 males and 2 females aged 44 to 67 years (mean 51.6 +/- 9.07 SD), who received a mean number of 4.33 IB treatments (+/-1.5; min: 3, max: 7). The mean retreatment interval was 3 months (+/-1.36; min: 2, max: 6). Four eyes (66.6%) showed a BCVA improvement (mean 3.4 lines) from baseline and two eyes (33.3%) did not show any change in visual acuity from baseline to last follow-up. Mean BCVA rose significantly from 22.5+/-14.4 letters at baseline to 35.8+/-21.5 letters at 30 months (p=0.025). Angiographic examinations showed reduction or cessation of the CNV leakage in all patients. OCT findings demonstrated slight CRT diminution (mean 41.6 µm). No intraocular pressure changes were observed after the IVB injection, which did not cause any systemic complication. No injection related back pain or IVB-induced ocular complication was reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioid Streaks, Choroidal Neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
intravitreal injection
Other Intervention Name(s)
intravitreal bevacizumab
Intervention Description
1.25 mg in 0.05 cc of bevacizumab
Intervention Type
Drug
Intervention Name(s)
intravitreal injection
Other Intervention Name(s)
intravitreal bevacizumab
Intervention Description
1.25 mg of bevacizumab intravitreally injected in a steril field
Primary Outcome Measure Information:
Title
BCVA improvement
Time Frame
6 months
Secondary Outcome Measure Information:
Title
reduction or cessation leakage
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: presence of an active CNV visual loss increased retinal thickness Exclusion Criteria: no actively leaking CNV by FAG normal retinal thickness satisfactory visual acuity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Rinaldi, MD
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dipartimento di Oftalmologia, SUN
City
Napoli
ZIP/Postal Code
80100
Country
Italy

12. IPD Sharing Statement

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Intravitreal Bevacizumab in Agioid Streaks

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