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OpenTrials
Completed

NCT Number: NCT00406250

Intravitreal Bevacizumab in Agioid Streaks

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

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Key information

Age range

44 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dipartimento di Oftalmologia, SUN

Naples, Napoli, 80100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravitreal injection

Drug

1.25 mg in 0.05 cc of bevacizumab

Other names: intravitreal bevacizumab

Primary outcomes

  1. BCVA improvement

    Time frame: 6 months

Secondary outcomes

  1. reduction or cessation leakage

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Intravitreal Bevacizumab for Choroidal Neovascularization Secondary to Angioid Streaks: 24 Months Follow-up

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Dec 4, 2006
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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