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

Phase 3

Completed

• Conditions: Choroidal Melanoma
• Interventions: Drug: Ranibizumab injection and TTT - ICG based

• Registration Number: NCT00680225
• Lead Sponsor: New England Retina Associates

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-20
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2017-04
• Results First Submitted: 2017-04-10
• Results First Submitted QC: 2017-04-10
• Last Update Submitted: 2017-04-10
• Results First Posted: 2017-04-12
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lucentis Injection	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.

Primary Outcome Measures

Name	Time	Method
Mean Tumor Thickness	12 mo

Secondary Outcome Measures

Name	Time	Method
Visual Acuity Changes	12 mo

Trial Locations

Locations (1)

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