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A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Choroidal Melanoma

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Trial Information

A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma


Inclusion Criteria:



- Patients with newly diagnosed choroidal melanoma undergoing proton therapy

- Tumors >15 mm in largest diameter and/or >5 mm in height (recruitment complete)

- Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic
disc and/or macula

- Best-corrected visual acuity 20/100 or better in study eye

Exclusion Criteria:

- History of prior treatment for choroidal melanoma

- Pregnancy or lactation

- Presence of diabetic retinopathy

- History of retinal vascular occlusion or other retinal vascular disease

- Active ocular inflammation or history of uveitis in either eye

- History of uncontrolled glaucoma (defined as intraocular pressure >30mmHg despite
treatment with anti-glaucoma medication) or filtering surgery in the study eye

- Previous intravitreal injections of Avastin® in the study eye or in the non-study eye
within 30 days.

- Concurrent use of systemic anti-VEGF therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

incidence and severity of ocular adverse events and systemic adverse events

Outcome Time Frame:

12 months and 24 months after initial treatment

Safety Issue:

Yes

Principal Investigator

Ivana Kim, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts Eye and Ear Infirmary

Authority:

United States: Food and Drug Administration

Study ID:

07-06-040

NCT ID:

NCT00765921

Start Date:

June 2008

Completion Date:

December 2013

Related Keywords:

  • Choroidal Melanoma
  • glaucoma, neovascular
  • macular edema
  • eye enucleation
  • antibodies, monoclonal
  • radiation oncology
  • Melanoma

Name

Location

Massachusetts Eye & Ear InfirmaryBoston, Massachusetts  02114