Clinical trial · Interventional
Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)
Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma
NCT01251978CI-TRIAL-00024354completedPhase 2Results 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)
Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.5 mg Ranibizumab | Drug | — | UNRESOLVED |
| Ranibizumab 2 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- High dose Ranibizumab
- description
- 6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
- interventionNames
- Drug: Ranibizumab 2 mg
- type
- ACTIVE_COMPARATOR
- label
- Standard Dose Ranibizumab
- description
- 6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.
- interventionNames
- Drug: 0.5 mg Ranibizumab
Primary outcomes (1)
- measure
- To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older * Primary pigmented or amelanotic choroidal melanoma measuring 16 mm or less in the largest basal diameter and 6 mm or less in the apical height. * Location of the tumor, posterior to the equator of the eye. * Documented growth of tumor by A-B scan. * Ability to provide written informed consent and comply with the study assessment for the full duration of the study. Exclusion Criteria: * Pregnancy or lactation. * Premenopausal women not using adequate contraception. * Current infection or inflammation in either eye. * Extension of tumor into the orbit. * Regional 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.