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

Information source: New England Retina Associates
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Choroidal Melanoma

Intervention: Ranibizumab 2 mg (Drug); 0.5 mg Ranibizumab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: New England Retina Associates

Official(s) and/or principal investigator(s):
Peter E Liggett, MD, Principal Investigator, Affiliation: 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: 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 using the incidence and severity of adverse events.

Secondary outcome: Tumor destruction or reduction as documented by fundus photography, fluorescein angiography and ultrasonographic imaging.

Eligibility

Minimum age: 50 Years. Maximum age: 90 Years. Gender(s): Both.

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.

Locations and Contacts

New England Retina Associates, Hamden, Connecticut 06518, United States
Additional Information

New England Retina Associates website. It contains all the clinical trials that we are running.

Starting date: July 2010
Last updated: May 1, 2013

Page last updated: August 23, 2015

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