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Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

Information source: California Retina Consultants
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Age Related Macular Degeneration; Choroidal Neovascularization; Macular Edema

Intervention: Bevacizumab and verteporfin photodynamic therapy (Drug); Bevacizumab and visudyne photodynamic therapy (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: California Retina Consultants

Official(s) and/or principal investigator(s):
Dante J Pieramici, MD, Principal Investigator, Affiliation: California Retina Consultants

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.

Clinical Details

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

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

Primary outcome:

Visual Acuity: Percentage of patients losing 3 or more lines(15 letters) of visual acuity from baseline.

Visual acuity: Percentage of patients gaining 3 or more lines(15 letters) of VA from baseline.

Secondary outcome: Ocular or systemic adverse events

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

California Retina Consultants, Bakersfield, California 93309, United States

California Retina Consultants, Santa Barbara, California 93103, United States

Additional Information

Starting date: May 2006
Last updated: December 10, 2013

Page last updated: August 23, 2015

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