Choroidal Melanoma
Conditions
Keywords
Choroidal melanoma, Lucentis, TTT-ICG
Brief summary
To report preliminary results on safety and tolerability of intravitreal injection of Ranibizumab (Lucentis) combined with Transpupillary Thermotherapy (TTT)+ Indocyanine Green (ICG)-based photodynamic therapy (PDT) in the treatment of choroidal melanoma.
Interventions
DRUGRanibizumab 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.
Sponsors
New England Retina Associates
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Age \> 18 yo. * Primary pigmented or amelanotic choroidal melanoma measurement of 16 mm or less in the largest vessel diameter and 6 mm or less in the apical height. * Location of the tumor posterior to the equator. * Documented growth by A/B scan. * Risk factor for metastasis (thickness greater than 2 mm, symptoms, tumor margin at the optic disc) * Ability to provide inform consent. * Comply with the study assessment for the cooperation of the study.
Exclusion criteria
* Pregnancy or lactation. * Premenopausal women not using adequate contraception; surgical sterilization or use of oral contraception, barrier contraception with either a condom or diaphragm or in conjunction with spermicidal gel, an IUD or contraceptive hormon implant or patch. * Current infection or inflammation in either eye. * Extension of tumor into the orbit. * Retinal spread or metastatic disease. * Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. * Any known allergy to any of the components to be used in the study. * Participation in another simultaneous medical investigation or trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Tumor Thickness | 12 mo |
Secondary
| Measure | Time frame |
|---|---|
| Visual Acuity Changes | 12 mo |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Lucentis Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Mean Tumor Thickness
Time frame: 12 mo
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lucentis Injection | Mean Tumor Thickness | 2.91 mm |
Secondary
Visual Acuity Changes
Time frame: 12 mo
Population: PI has left the institution and summary data are not available.