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

NCT00680225 | Completed Phase 3 Results

• 1 other identifier: FVF4290s
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Choroidal Melanoma

Keywords

Choroidal melanoma; Lucentis; TTT-ICG

Outcome Measures

Primary Outcomes (1)

• Mean Tumor Thickness

  12 mo

Secondary Outcomes (1)

• Visual Acuity Changes

  12 mo

Study Arms (1)

Lucentis Injection

EXPERIMENTAL

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.

Drug: Ranibizumab injection and TTT - ICG based

Interventions

Ranibizumab injection and TTT - ICG based DRUG

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.

Also known as: Lucentis injection

Lucentis Injection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New England Retina Associates: lead

Study Sites (1)

New England Retina Associates

Hamden, Connecticut, 06518, United States

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Peter Liggett
• Organization: New England Retina Associates

neretina@msn.com

203-288-2020

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 20, 2008
• Study Start: September 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 12, 2017
• Results First Posted: April 12, 2017

Record last verified: 2017-04

Locations

US (1)