Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

NCT ID: NCT00729846

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-07-31

Brief Summary

To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic therapy at standard or reduced fluence level in patients with subfoveal CNV due to age-related macular degeneration.

Conditions

Age Related Macular Degeneration; Choroidal Neovascularization; Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Patients will receive combination verteporfin with photodynamic therapy at reduced fluence \[300mw/cm2\] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.

verteporfin photodynamic therapy reduced fluence

Intervention Type: DEVICE

Patients will receive combination verteporfin photodynamic therapy with stand fluence \[600mW/cm2\].

B

Patients will receive combination verteporfin with photodynamic therapy at standard fluence \[600mw/cm2\] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.

verteporfin photodynamic therapy standardfluence

Intervention Type: DEVICE

Patients will receive combination verteporfin with photodynamic therapy at standard fluence \[600mw/cm2\].

Interventions

Bevacizumab

Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.

Intervention Type: DRUG

verteporfin photodynamic therapy reduced fluence

Patients will receive combination verteporfin photodynamic therapy with stand fluence \[600mW/cm2\].

Intervention Type: DEVICE

verteporfin photodynamic therapy standardfluence

Patients will receive combination verteporfin with photodynamic therapy at standard fluence \[600mw/cm2\].

Intervention Type: DEVICE

Other Intervention Names

Avastin, visudyne; PDT

Eligibility Criteria

Inclusion Criteria

• Patients are men or women of age 50 or older.
• Patients have not received previous treatment for subfoveal choroidal neovascularization (CNV).
• Patients must have evidence of active or recurrent subfoveal CNV as confirmed by fluorescein angiography.
• The total lesion must be less than or equal to 9 disc areas in size, with a greatest linear distance of 5400 microns.
• Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye. Only one eye will assessed in the study.
• The CNV lesion must be primarily CNV (i.e. CNV equal to or greater than 50% of the lesion.
• The CNV is associated with only macular degeneration.
• Patient defers other approved treatments of subfoveal CNV associated with AMD.

Exclusion Criteria

• Prior treatment for subfoveal choroidal neovascularization (CNV).
• Prior treatment for juxtafoveal or extrafoveal CNV involving previous antiangiogenic agent, photodynamic therapy, or intravitreal triamcinolone acetate.
• History of vitrectomy or submacular surgery in the study eye.
• Subretinal fibrosis accounting for more than 50% of the lesion.
• Non-CNV lesion components account for more than 50% of the total lesion components.
• CNV due to causes other than AMD.
• Retinal pigmented epithelial tear involving the center of the macula.
• Geographic atrophy involving the central macula.
• Any concurrent intraocular condition in the study eye that in the opinion of the investigator could require surgical or medical intervention during the course of the study (i.e. cataract).
• Active intraocular inflammation.
• Vitreous hemorrhage in the eye.
• History of spherical equivalent in the study eye greater than negative 8 diopters.
• Intraocular surgery within 2 months of study enrollment.
• Uncontrolled glaucoma in the study eye. Defined as intraocular pressure greater than 30mmHg despite treatment with anti-glaucoma medication.
• History of other disease, such as recent myocardial infarction, recent cerebral vascular accident, or uncontrolled hypertension that in the opinion of the investigator might render the subject at high risk for complication.
• Inability to comply with study or follow-up procedures.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

California Retina Consultants

OTHER

Sponsor Role: lead

Responsible Party

Dante Pieramici

Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dante J Pieramici, MD

Role: PRINCIPAL_INVESTIGATOR

California Retina Consultants

Locations

California Retina Consultants

Bakersfield, California, United States

California Retina Consultants

Santa Barbara, California, United States

Countries

United States

Related Links

http://www.californiaretina.com

California Retina Consultants Website

Other Identifiers

BPDT2006

Identifier Type: -

Identifier Source: org_study_id