Phase 3
N=10
Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma
Choroidal Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00680225 ↗Enrolled (actual)
10
Serious AEs
—
Results posted
Apr 2017
Primary outcome: Primary: Mean Tumor Thickness — 2.91 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ranibizumab injection and TTT - ICG based (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New England Retina Associates
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Tumor Thickness |
2.91 | — |
| SECONDARY Visual Acuity Changes |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00680225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.