Clinical trial · Interventional
Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma
Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma
NCT00680225CI-TRIAL-00026938completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Choroidal Melanoma | Choroid Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ranibizumab injection and TTT - ICG based | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lucentis Injection
- description
- 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.
- interventionNames
- Drug: Ranibizumab injection and TTT - ICG based
Primary outcomes (1)
- measure
- Mean Tumor Thickness
- timeFrame
- 12 mo
Secondary outcomes (1)
- measure
- Visual Acuity Changes
- timeFrame
- 12 mo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.