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Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma

2014-08-27 03:35:42 | BioPortfolio

Summary

A one year interventional study to test the safety and tolerability of monthly basis intravitreal injection of ranibizumab combined with Transpupillary Thermo Therapy + ICG-based photodynamic therapy in the treatment of choroidal melanoma.

Description

10 patients with clinical evaluation, A-B scan and Fluorescein Angiogram proven choroidal melanoma will be recruited for this single-center, non-randomized, open-label, active treatment study of intravitreal ranibizumab combined with TTT + ICG-based photodynamic therapy . They will receive intravitreal injections of 0.5 mg ranibizumab administered every 30 days (+/- 7 days) for the first 6 months and as necessary in the succeeding 6 months if there is no decrease or instability in tumor size. They will also receive 1 session of TTT + ICG-based photodynamic therapy at the first month and as needed in the following month.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Choroidal Melanoma

Intervention

Ranibizumab

Location

New England Retina Associates
Hamden
Connecticut
United States
06518

Status

Recruiting

Source

New England Retina Associates

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:35:42-0400

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Medical and Biotech [MESH] Definitions

An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)

Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.

A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.

Found in large amounts in the plasma and urine of patients with malignant melanoma. It is therefore used in the diagnosis of melanoma and for the detection of postoperative metastases. Cysteinyldopa is believed to be formed by the rapid enzymatic hydrolysis of 5-S-glutathionedopa found in melanin-producing cells.

A melanosome-specific protein that plays a role in the expression, stability, trafficking, and processing of GP100 MELANOMA ANTIGEN, which is critical to the formation of Stage II MELANOSOMES. The protein is used as an antigen marker for MELANOMA cells.

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