Intravitreal Bevacizumab in Agioid Streaks

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

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

Study Overview

• Status: Completed
• Conditions: Choroidal Neovascularization; Angioid Streaks
• Intervention / Treatment: Drug: intravitreal injection; Drug: intravitreal injection

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80100
    • Dipartimento di Oftalmologia, SUN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 44 years to 67 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bevacizumab	Drug: intravitreal injection; 1.25 mg in 0.05 cc of bevacizumab; Other Names: intravitreal bevacizumab; Drug: intravitreal injection; 1.25 mg of bevacizumab intravitreally injected in a steril field; Other Names: intravitreal bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BCVA improvement	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
reduction or cessation leakage	6 months

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"
• Investigators: Principal Investigator: Michele Rinaldi, MD, University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): May 1, 2009

Study Registration Dates

• First Submitted: November 30, 2006
• First Submitted That Met QC Criteria: November 30, 2006
• First Posted (ESTIMATE): December 4, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): February 8, 2016
• Last Update Submitted That Met QC Criteria: February 5, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Diseases; Uveal Diseases; Choroid Diseases; Metaplasia; Choroidal Neovascularization; Neovascularization, Pathologic; Angioid Streaks; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: 81612