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

Choroidal Melanoma Clinical Trial

Official title:

Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251978
• Other study ID #: FVF4927s
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2010
• Last updated: October 17, 2016
• Start date: July 2010
• Est. completion date: August 2012

Study information

• Verified date: October 2016
• Source: New England Retina Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Melanoma
• Melanoma

Intervention

Drug:
• Ranibizumab 2 mg
intravitreal injections of ranibizumab once a month, times 3.
• 0.5 mg Ranibizumab
6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.

Locations

Country	Name	City	State
United States	New England Retina Associates	Hamden	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
New England Retina Associates	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.		1 year	Yes
Secondary	Tumor Thickness		baseline and 1 year	Yes
Secondary	Visual Acuity (LogMar)		12 months	No

External Links

•   New England Retina Associates website. It contains all the clinical trials that we are running.