NCT01251978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

October 19, 2016

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

November 30, 2010

Results QC Date

October 17, 2016

Last Update Submit

October 17, 2016

Conditions

Choroidal Melanoma

Keywords

Choroidal melanomaRanibizumabTranspupillary ThermotherapyCSTIPIndocyanine Green

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (2)

  • Tumor Thickness

    baseline and 1 year

  • Visual Acuity (LogMar)

    12 months

Study Arms (2)

High dose Ranibizumab

ACTIVE COMPARATOR

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

Drug: Ranibizumab 2 mg

Standard Dose Ranibizumab

ACTIVE COMPARATOR

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

Drug: 0.5 mg Ranibizumab

Interventions

Ranibizumab 2 mgDRUG

intravitreal injections of ranibizumab once a month, times 3.

High dose Ranibizumab
0.5 mg RanibizumabDRUG

6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.

Standard Dose Ranibizumab

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New England Retina Associates

Hamden, Connecticut, 06518, United States

Location

Related Links

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Leslie Hurst- study coordinator
Organization
New England Retina Associates
lhurst@retinamd.com
203-288-2020

Study Officials

  • Peter E Liggett, MD

    New England Retina Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 2, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

October 19, 2016

Results First Posted

October 19, 2016

Record last verified: 2016-10

Locations

US(1)