Trial Outcomes & Findings for Lucentis Utilizing Visudyne (LUV Trial) Combination Therapy in the Treatment of Age-Related Macular Degeneration (NCT NCT00423189)
NCT ID: NCT00423189
Last Updated: 2016-03-04
Results Overview
Visual Acuity was measured by ETDRS by certified refractionists in certified lanes at 12 months. Visual Acuity was not measured by ETDRS at 6 months.
TERMINATED
PHASE4
7 participants
1 Year
2016-03-04
Participant Flow
7 patients, over a 12 month period were followed after receiving treatment of either decreased fluence(2 different fluences) and 0.5mg ranibizumab, as compared to monotherapy of 0.5mg ranibizumab at a single site
patients that were considered to have recalcitrant wet age related macular degeneration were recruited for this trial
Participant milestones
| Measure |
Ranibizumab Only
drug - intravitreal ranibizumab
|
Ranibizumab and 40% Fluence PDT(Procedure)
40% fluence photodynamic therapy - procedure
|
Ranibizumab and 20% Fluence PDT(Procedure)
20% fluence photodynamic therapy - procedure
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Ranibizumab Only
drug - intravitreal ranibizumab
|
Ranibizumab and 40% Fluence PDT(Procedure)
40% fluence photodynamic therapy - procedure
|
Ranibizumab and 20% Fluence PDT(Procedure)
20% fluence photodynamic therapy - procedure
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
Baseline Characteristics
Lucentis Utilizing Visudyne (LUV Trial) Combination Therapy in the Treatment of Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Arm 1
n=2 Participants
drug - intravitreal ranibizumab
|
Arm 2
n=3 Participants
40% fluence photodynamic therapy - procedure
|
Arm 3
n=2 Participants
20% fluence photodynamic therapy - procedure
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 3 • n=5 Participants
|
78 years
STANDARD_DEVIATION 7 • n=7 Participants
|
67 years
STANDARD_DEVIATION 5 • n=5 Participants
|
72 years
STANDARD_DEVIATION 5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
03 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 YearPopulation: As per subjects participated
Visual Acuity was measured by ETDRS by certified refractionists in certified lanes at 12 months. Visual Acuity was not measured by ETDRS at 6 months.
Outcome measures
| Measure |
Ranibizumab Only
n=2 Participants
IVT Ranibizumab only
|
40% Fluence PDT/Ranibizumab
n=3 Participants
40% Fluence PDT WITH ivt Ranibizumab
|
20% Fluence PDT/Ranibizumab
n=2 Participants
20% Fluence PDT with IVT Ranibizumab
|
|---|---|---|---|
|
Best-corrected ETDRS Visual Acuity at 6 Months and 12 Months Only Time Points (Gain or Loss of >15 Letters at 12 Months)
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 YearPopulation: not determined due to lack of efficacy
Number of intravitreal injections with ranibizumab needed by patients at 12 months was not determined due to lack of efficacy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 YearOCT 3 macular thickness improvement at Baseline-1month, 2months, 3months, 6months \&12 months was not determined due to lack of efficacy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 YearChoroidal perfusion as assessed by ICG angiography at 1, 2, 3, 6, and 12 months was not determined due to lack of efficacy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 YearSafety of combination therapy with verteporfin PDT and ITV ranibizumab was not determined due to lack of efficacy.
Outcome measures
Outcome data not reported
Adverse Events
Ranibizumab Only
40% Fluence PDT Combined With Ranibizumab
20% PDT Fluence Combined With Ranibizumab
Serious adverse events
| Measure |
Ranibizumab Only
n=2 participants at risk
subject only received ranibizumab
|
40% Fluence PDT Combined With Ranibizumab
n=3 participants at risk
Subjects who have received 40% fluence PDT combined with as needed dosing with ranibizumab
|
20% PDT Fluence Combined With Ranibizumab
n=2 participants at risk
Subjects who received 20% with as needed ranibizumab
|
|---|---|---|---|
|
Eye disorders
Death of unknown origin
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
Other adverse events
| Measure |
Ranibizumab Only
n=2 participants at risk
subject only received ranibizumab
|
40% Fluence PDT Combined With Ranibizumab
n=3 participants at risk
Subjects who have received 40% fluence PDT combined with as needed dosing with ranibizumab
|
20% PDT Fluence Combined With Ranibizumab
n=2 participants at risk
Subjects who received 20% with as needed ranibizumab
|
|---|---|---|---|
|
Eye disorders
1+ Nuclear Sclerosis
|
50.0%
1/2 • Number of events 2
|
33.3%
1/3 • Number of events 3
|
50.0%
1/2 • Number of events 2
|
|
Eye disorders
2+ nuclear sclerosis
|
50.0%
1/2 • Number of events 2
|
33.3%
1/3 • Number of events 3
|
50.0%
1/2 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place