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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Choroidal Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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High dose Ranibizumab

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

Group Type ACTIVE_COMPARATOR

Ranibizumab 2 mg

Intervention Type DRUG

intravitreal injections of ranibizumab once a month, times 3.

Standard Dose Ranibizumab

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

Group Type ACTIVE_COMPARATOR

0.5 mg Ranibizumab

Intervention Type DRUG

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

Interventions

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Ranibizumab 2 mg

intravitreal injections of ranibizumab once a month, times 3.

Intervention Type DRUG

0.5 mg Ranibizumab

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No