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Intravitreal Bevacizumab in Agioid Streaks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00406250
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : February 8, 2016
Information provided by (Responsible Party):
Chiosi Flavia, University of Campania "Luigi Vanvitelli"

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.

Condition or disease Intervention/treatment Phase
Angioid Streaks Choroidal Neovascularization Drug: intravitreal injection Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab for Choroidal Neovascularization Secondary to Angioid Streaks: 24 Months Follow-up
Study Start Date : November 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Bevacizumab Drug: intravitreal injection
1.25 mg in 0.05 cc of bevacizumab
Other Name: intravitreal bevacizumab

Drug: intravitreal injection
1.25 mg of bevacizumab intravitreally injected in a steril field
Other Name: intravitreal bevacizumab

Primary Outcome Measures :
  1. BCVA improvement [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. reduction or cessation leakage [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   44 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00406250

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Dipartimento di Oftalmologia, SUN
Napoli, Italy, 80100
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
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Principal Investigator: Michele Rinaldi, MD University of Campania "Luigi Vanvitelli"

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Responsible Party: Chiosi Flavia, University of Campania "Luigi Vanvitelli" Identifier: NCT00406250     History of Changes
Other Study ID Numbers: 81612
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Choroidal Neovascularization
Angioid Streaks
Neovascularization, Pathologic
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases
Retinal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors