Trial Outcomes & Findings for Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma (NCT NCT00680225)
NCT ID: NCT00680225
Last Updated: 2017-04-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
10 participants
Primary outcome timeframe
12 mo
Results posted on
2017-04-12
Participant Flow
Participant milestones
| Measure |
Lucentis Injection
Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma
Baseline characteristics by cohort
| Measure |
Lucentis Injection
n=8 Participants
Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 moOutcome measures
| Measure |
Lucentis Injection
n=8 Participants
Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
|
|---|---|
|
Mean Tumor Thickness
|
2.91 mm
Interval 2.5 to 3.5
|
SECONDARY outcome
Timeframe: 12 moPopulation: PI has left the institution and summary data are not available.
Outcome measures
Outcome data not reported
Adverse Events
Lucentis Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place