Status:
COMPLETED
Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)
Lead Sponsor:
California Retina Consultants
Collaborating Sponsors:
Novartis
Conditions:
Age Related Macular Degeneration
Choroidal Neovascularization
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00729846
Start Date
May 1 2006
End Date
July 1 2009
Last Update
April 20 2016
Active Locations (2)
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1
California Retina Consultants
Bakersfield, California, United States, 93309
2
California Retina Consultants
Santa Barbara, California, United States, 93103