Phase 2
N=8
Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)
Choroidal Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01251978 ↗Enrolled (actual)
8
Serious AEs
—
Results posted
Oct 2016
Primary outcome: Primary: 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. — 4; 1; 1; 1 participant
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ranibizumab 2 mg (Drug); 0.5 mg Ranibizumab (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- New England Retina Associates
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
4; 1; 1; 1; 1 | — |
| SECONDARY Tumor Thickness |
4.85; 2.91; 2.68; 0.79 | — |
| SECONDARY Visual Acuity (LogMar) |
NA; 0.1; NA; 0.1; NA; 1.21 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01251978). 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.