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Intravitreal Bevacizumab in Agioid Streaks

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00406250
First Posted: December 4, 2006
Last Update Posted: February 8, 2016
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.
Information provided by (Responsible Party):
Chiosi Flavia, Second University of Naples
  Purpose
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 Intervention Phase
Angioid Streaks Choroidal Neovascularization Drug: intravitreal injection Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Chiosi Flavia, Second University of Naples:

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

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

Enrollment: 5
Study Start Date: November 2006
Study Completion Date: May 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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Ages Eligible for Study:   44 Years to 67 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00406250


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

Responsible Party: Chiosi Flavia, Second University of Naples
ClinicalTrials.gov Identifier: NCT00406250     History of Changes
Other Study ID Numbers: 81612
First Submitted: November 30, 2006
First Posted: December 4, 2006
Last Update Posted: February 8, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Angioid Streaks
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases
Retinal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents