Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)
Condition: Age Related Macular Degeneration; Choroidal Neovascularization; Macular Edema
MeSH terms: Macular Degeneration; Macular Edema; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Bevacizumab; verteporfin photodynamic therapy reduced fluence; verteporfin photodynamic therapy standardfluence
Intervention description: Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.; Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2].; Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2].
Intervention MeSH terms: Bevacizumab; Verteporfin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: choroidal neovascularization; macular degeneration; macular edema; intravitreal bevacizumab; vegf; verteporfin PDT

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.