Intravitreal Bevacizumab in Agioid Streaks

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Second University of Naples.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Second University of Naples
ClinicalTrials.gov Identifier:
NCT00406250
First received: November 30, 2006
Last updated: December 3, 2008
Last verified: December 2008
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Second University of Naples:

Primary Outcome Measures:
  • BCVA improvement [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • reduction or cessation leakage [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: November 2006
Estimated 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

Ages Eligible for Study:   44 Years to 67 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00406250

Locations
Italy
Dipartimento di Oftalmologia, SUN
Napoli, Italy, 80100
Sponsors and Collaborators
Second University of Naples
Investigators
Principal Investigator: Michele Rinaldi, MD Second University of Naples
  More Information

No publications provided

Responsible Party: Ophthalmology department, Seconda Università degli Studi di Napoli
ClinicalTrials.gov Identifier: NCT00406250     History of Changes
Other Study ID Numbers: 81612
Study First Received: November 30, 2006
Last Updated: December 3, 2008
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on October 20, 2014