Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

Macular Edema Clinical Trial

Official title:

Combination Bevacizumab and Verteporfin (Standard and Reduced Fluence)in the Treatment of Neovascular Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729846
• Other study ID #: BPDT2006
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2008
• Last updated: December 10, 2013
• Start date: May 2006
• Est. completion date: July 2009

Study information

• Verified date: December 2013
• Source: California Retina Consultants
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Macular Edema
• Neovascularization, Pathologic

Intervention

Drug:
• Bevacizumab and verteporfin photodynamic therapy
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.
• Bevacizumab and visudyne photodynamic therapy
Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy.

Locations

Country	Name	City	State
United States	California Retina Consultants	Bakersfield	California
United States	California Retina Consultants	Santa Barbara	California

Sponsors (2)

Lead Sponsor	Collaborator
California Retina Consultants	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity: Percentage of patients losing 3 or more lines(15 letters) of visual acuity from baseline.		1 Year	Yes
Primary	Visual acuity: Percentage of patients gaining 3 or more lines(15 letters) of VA from baseline.		1 Year	Yes
Secondary	Ocular or systemic adverse events		1 Year	Yes

External Links

•   California Retina Consultants Website