Intravitreal Bevacizumab in Agioid Streaks

NCT ID: NCT00406250

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2009-05-31

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.

Conditions

Angioid Streaks; Choroidal Neovascularization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab

Group Type: EXPERIMENTAL

intravitreal injection

Intervention Type: DRUG

1.25 mg in 0.05 cc of bevacizumab

intravitreal injection

Intervention Type: DRUG

1.25 mg of bevacizumab intravitreally injected in a steril field

Interventions

intravitreal injection

1.25 mg in 0.05 cc of bevacizumab

Intervention Type: DRUG

intravitreal injection

1.25 mg of bevacizumab intravitreally injected in a steril field

Intervention Type: DRUG

Other Intervention Names

intravitreal bevacizumab; intravitreal bevacizumab

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

• Minimum Eligible Age: 44 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Chiosi Flavia

Chiosi Flavia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Rinaldi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Campania Luigi Vanvitelli

Locations

Dipartimento di Oftalmologia, SUN

Napoli, Napoli, Italy

Countries

Italy

Other Identifiers

81612

Identifier Type: -

Identifier Source: org_study_id