Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma
Information source: New England Retina Associates
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Choroidal Melanoma
Intervention: Ranibizumab injection and TTT - ICG based (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: New England Retina Associates
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.
Clinical Details
Official title: Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Reduction in tumor size
Secondary outcome: Visual acuity changes
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
New England Retina Associates, Hamden, Connecticut 06518, United States
Additional Information
Starting date: September 2007
Last updated: May 1, 2013
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