Trial Outcomes & Findings for Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration (NCT NCT00473642)
NCT ID: NCT00473642
Last Updated: 2020-11-06
Results Overview
Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
12 months
Results posted on
2020-11-06
Participant Flow
Participant milestones
| Measure |
Standard Fluence PDT
Standard Fluence Photodynamic Therapy combined with ranibizumab
|
50% Fluence PDT
Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
|
Ranibizumab
Ranibizumab monotherapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Standard Fluence PDT
n=10 Participants
Standard Fluence Photodynamic Therapy combined with ranibizumab
|
50% Fluence PDT
n=11 Participants
Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
|
Ranibizumab
n=10 Participants
Ranibizumab monotherapy
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Age, Continuous
|
76.9 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
73.4 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
76.3 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
74 years
STANDARD_DEVIATION 2.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
31 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsVisual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.
Outcome measures
| Measure |
Standard Fluence PDT
n=10 Participants
Standard Fluence Photodynamic Therapy combined with ranibizumab
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Verteporfin: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
|
Reduced Fluence PDT
n=11 Participants
Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Verteporfin: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)
|
Ranibizumab Monotherapy
n=10 Participants
Ranibizumab monotherapy
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
|
|---|---|---|---|
|
Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months
|
5.9 Letters
Interval -0.4 to 12.2
|
7.6 Letters
Interval 3.6 to 11.6
|
16.4 Letters
Interval 12.4 to 20.4
|
PRIMARY outcome
Timeframe: 12 monthsVisual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.
Outcome measures
| Measure |
Standard Fluence PDT
n=10 Participants
Standard Fluence Photodynamic Therapy combined with ranibizumab
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Verteporfin: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
|
Reduced Fluence PDT
n=11 Participants
Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Verteporfin: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)
|
Ranibizumab Monotherapy
n=10 Participants
Ranibizumab monotherapy
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
|
|---|---|---|---|
|
Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol
|
5.9 letters
Standard Deviation 6.3
|
7.6 letters
Standard Deviation 4
|
16.4 letters
Standard Deviation 4
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Standard Fluence PDT
n=10 Participants
Standard Fluence Photodynamic Therapy combined with ranibizumab
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Verteporfin: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
|
Reduced Fluence PDT
n=11 Participants
Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Verteporfin: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)
|
Ranibizumab Monotherapy
n=10 Participants
Ranibizumab monotherapy
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
|
|---|---|---|---|
|
Time to First Retreatment After Loading Doses
|
2.86 Month
Standard Deviation 0.38
|
2.90 Month
Standard Deviation 0.71
|
2.86 Month
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Standard Fluence PDT
n=10 Participants
Standard Fluence Photodynamic Therapy combined with ranibizumab
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Verteporfin: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
|
Reduced Fluence PDT
n=11 Participants
Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Verteporfin: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)
|
Ranibizumab Monotherapy
Ranibizumab monotherapy
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
|
|---|---|---|---|
|
Average Number of PDT Retreatments Over 12 Months
|
0.67 Number of Treatments
Standard Deviation 0.24
|
0.55 Number of Treatments
Standard Deviation 0.22
|
—
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Standard Fluence PDT
n=10 Participants
Standard Fluence Photodynamic Therapy combined with ranibizumab
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Verteporfin: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
|
Reduced Fluence PDT
n=11 Participants
Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Verteporfin: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)
|
Ranibizumab Monotherapy
n=10 Participants
Ranibizumab monotherapy
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
|
|---|---|---|---|
|
Central Macular Thickness Reduction on OCT
|
42.9 micron (um)
Standard Deviation 20.1
|
76.1 micron (um)
Standard Deviation 37.8
|
34.9 micron (um)
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Standard Fluence PDT
n=10 Participants
Standard Fluence Photodynamic Therapy combined with ranibizumab
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Verteporfin: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
|
Reduced Fluence PDT
n=11 Participants
Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Verteporfin: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)
|
Ranibizumab Monotherapy
n=10 Participants
Ranibizumab monotherapy
Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL
|
|---|---|---|---|
|
Average Number of Ranibizumab Retreatments Over 12 Months
|
2.67 Number of Treatments
Standard Deviation 0.53
|
2.91 Number of Treatments
Standard Deviation 0.62
|
4.14 Number of Treatments
Standard Deviation 0.72
|
Adverse Events
Standard Fluence PDT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
50% Fluence PDT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ranibizumab
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Fluence PDT
n=10 participants at risk
Standard Fluence Photodynamic Therapy combined with ranibizumab
|
50% Fluence PDT
n=11 participants at risk
Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
|
Ranibizumab
n=10 participants at risk
Ranibizumab monotherapy
|
|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
cardiopulmonary arrest
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60