Age Related Macular Degeneration, Choroidal Neovascularization, Macular Edema
Conditions
Keywords
choroidal neovascularization, macular degeneration, macular edema, intravitreal bevacizumab, vegf, verteporfin PDT
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.
Interventions
DEVICEverteporfin photodynamic therapy reduced fluence
Patients will receive combination verteporfin photodynamic therapy with stand fluence \[600mW/cm2\].
DEVICEverteporfin photodynamic therapy standardfluence
Patients will receive combination verteporfin with photodynamic therapy at standard fluence \[600mw/cm2\].
DRUGBevacizumab
Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
Sponsors
Novartis
California Retina Consultants
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline. | 1 Year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reduced Fluence Reduced Fluence
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. | 11 |
| Standard Fluence Standard Fluence
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. | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | Total | Reduced Fluence | Standard Fluence |
|---|---|---|---|
| Age, Continuous | 81.4 years | 79.0 years | 83.8 years |
| Region of Enrollment United States | 22 participants | 11 participants | 11 participants |
| Sex: Female, Male Female | 11 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 3 Participants |
| visual acuity | 57.34 ETDRS letters STANDARD_DEVIATION 10.8 | 54.18 ETDRS letters STANDARD_DEVIATION 13.7 | 60.5 ETDRS letters STANDARD_DEVIATION 7.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.
Time frame: 1 Year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reduced Fluence | Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline. | 80 percent of participants |
| Standard Fluence | Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline. | 90 percent of participants |