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Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)

Primary Purpose

Choroidal Melanoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab 2 mg
0.5 mg Ranibizumab
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, Ranibizumab, Transpupillary Thermotherapy, CSTIP, Indocyanine Green

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • Primary pigmented or amelanotic choroidal melanoma measuring 16 mm or less in the largest basal diameter and 6 mm or less in the apical height.
  • Location of the tumor, posterior to the equator of the eye.
  • Documented growth of tumor by A-B scan.
  • Ability to provide written informed consent and comply with the study assessment for the full duration of the study.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Premenopausal women not using adequate contraception.
  • Current infection or inflammation in either eye.
  • Extension of tumor into the orbit.
  • Regional 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 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High dose Ranibizumab

Standard Dose Ranibizumab

Arm Description

6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart.

6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.

Outcomes

Primary Outcome Measures

To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.

Secondary Outcome Measures

Tumor Thickness
Visual Acuity (LogMar)

Full Information

First Posted
November 30, 2010
Last Updated
October 17, 2016
Sponsor
New England Retina Associates
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01251978
Brief Title
Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)
Official Title
Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New England Retina Associates
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Melanoma
Keywords
Choroidal melanoma, Ranibizumab, Transpupillary Thermotherapy, CSTIP, Indocyanine Green

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High dose Ranibizumab
Arm Type
Active Comparator
Arm Description
6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
Arm Title
Standard Dose Ranibizumab
Arm Type
Active Comparator
Arm Description
6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 2 mg
Intervention Description
intravitreal injections of ranibizumab once a month, times 3.
Intervention Type
Drug
Intervention Name(s)
0.5 mg Ranibizumab
Intervention Description
6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.
Primary Outcome Measure Information:
Title
To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Tumor Thickness
Time Frame
baseline and 1 year
Title
Visual Acuity (LogMar)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Primary pigmented or amelanotic choroidal melanoma measuring 16 mm or less in the largest basal diameter and 6 mm or less in the apical height. Location of the tumor, posterior to the equator of the eye. Documented growth of tumor by A-B scan. Ability to provide written informed consent and comply with the study assessment for the full duration of the study. Exclusion Criteria: Pregnancy or lactation. Premenopausal women not using adequate contraception. Current infection or inflammation in either eye. Extension of tumor into the orbit. Regional 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter E Liggett, MD
Organizational Affiliation
New England Retina Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
New England Retina Associates
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.retinamd.com
Description
New England Retina Associates website. It contains all the clinical trials that we are running.

Learn more about this trial

Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)

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