Trial Outcomes & Findings for Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT) (NCT NCT00729846)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

1 Year

Results posted on

2016-04-20

Participant milestones
Measure	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.	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.
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

Baseline characteristics by cohort
Measure	Reduced Fluence n=11 Participants 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.	Standard Fluence n=11 Participants 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.	Total n=22 Participants Total of all reporting groups
Age, Continuous	79.0 years n=5 Participants	83.8 years n=7 Participants	81.4 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
visual acuity	54.18 ETDRS letters STANDARD_DEVIATION 13.7 • n=5 Participants	60.5 ETDRS letters STANDARD_DEVIATION 7.9 • n=7 Participants	57.34 ETDRS letters STANDARD_DEVIATION 10.8 • n=5 Participants

Timeframe: 1 Year

Outcome measures
Measure	Reduced Fluence n=11 Participants 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.	Standard Fluence n=11 Participants 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.
Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.	80 percent of participants	90 percent of participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

California Retina Consultants

Phone: 8059631648