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Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma

NCT01251978•New England Retina Associates

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.

Eligibility

Age

50 - 90 years

Sex

ALL

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.

Locations (1)

New England Retina Associates

Hamden, Connecticut, United States

Key Dates

Start Date

July 1, 2010

Primary Completion Date

July 1, 2012

Completion Date

August 1, 2012

Last Updated

October 19, 2016

Enrollment

ACTUAL participants

Conditions

Choroidal Melanoma

Interventions

Ranibizumab 2 mg

DRUG

0.5 mg Ranibizumab

DRUG

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

NCT06007690

Choroidal MelanomaIndeterminate Lesions+2 more

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RECRUITING

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

NCT03941379

Choroidal MelanomaIndeterminate Lesions of Eye

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma

Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Study in Subjects With Small Primary Choroidal Melanoma

Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)