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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

Page last updated: August 23, 2015

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