Phase 3
Completed N=10
Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma
Choroidal Melanoma
Source: ClinicalTrials.gov NCT00680225 ↗
Enrolled (actual)
10
Serious AEs
—
Results posted
Apr 2017
Primary outcomePrimary: Mean Tumor Thickness — 2.91 mm
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Tumor Thickness |
2.91 | — |
| SECONDARY Visual Acuity Changes |
— | — |
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. Informational only — not medical advice.