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

Primary Purpose

Choroidal Melanoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab injection and TTT - ICG based
Sponsored by
New England Retina Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Melanoma focused on measuring Choroidal melanoma, Lucentis, TTT-ICG

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • New England Retina Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lucentis Injection

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean Tumor Thickness

Secondary Outcome Measures

Visual Acuity Changes

Full Information

First Posted
May 15, 2008
Last Updated
April 10, 2017
Sponsor
New England Retina Associates
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1. Study Identification

Unique Protocol Identification Number
NCT00680225
Brief Title
Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma
Official Title
Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New England Retina Associates

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Melanoma
Keywords
Choroidal melanoma, Lucentis, TTT-ICG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lucentis Injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab injection and TTT - ICG based
Other Intervention Name(s)
Lucentis injection
Intervention Description
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 Measure Information:
Title
Mean Tumor Thickness
Time Frame
12 mo
Secondary Outcome Measure Information:
Title
Visual Acuity Changes
Time Frame
12 mo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
New England Retina Associates
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States

12. IPD Sharing Statement

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

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