Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)

Phase 2

Completed

• Conditions: Choroidal Melanoma
• Interventions: Drug: Ranibizumab 2 mg; Drug: 0.5 mg Ranibizumab

• Registration Number: NCT01251978
• Lead Sponsor: New England Retina Associates

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-02
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2016-10
• Results First Submitted: 2016-10-17
• Results First Submitted QC: 2016-10-17
• Last Update Submitted: 2016-10-17
• Results First Posted: 2016-10-19
• Last Update Posted: 2016-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose Ranibizumab	Ranibizumab 2 mg	6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
Standard Dose Ranibizumab	0.5 mg Ranibizumab	6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.

Primary Outcome Measures

Name	Time	Method
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.	1 year

Secondary Outcome Measures

Name	Time	Method
Visual Acuity (LogMar)	12 months
Tumor Thickness	baseline and 1 year

Trial Locations

Locations (1)

New England Retina Associates; 🇺🇸 Hamden, Connecticut, United States