Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma

Choroidal Melanoma Clinical Trial

Official title:

Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680225
• Other study ID #: FVF4290s
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2008
• Last updated: April 10, 2017
• Start date: September 2007
• Est. completion date: July 2012

Study information

• Verified date: April 2017
• Source: New England Retina Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00541528

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Choroidal Melanoma
• Melanoma

Intervention

Drug:
• Ranibizumab injection and TTT - ICG based
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
New England Retina Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Tumor Thickness		12 mo
Secondary	Visual Acuity Changes		12 mo