Clinical trial NCT00729846: Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)
Official title: Combination Bevacizumab and Verteporfin (Standard and Reduced Fluence)in the Treatment of Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age Related Macular Degeneration
Choroidal Neovascularization
Macular Edema
Keywords: choroidal neovascularization
macular degeneration
macular edema
intravitreal bevacizumab
vegf
verteporfin PDT
Lead sponsor: California Retina Consultants
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2008-08-08
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
Study officials:
affiliation: California Retina Consultants
name: Dante J Pieramici, MD
role: PRINCIPAL_INVESTIGATOR
References: