Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/3/2016 |
| Start Date: | June 2008 |
| End Date: | September 2016 |
A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
The purpose of the study is to investigate the safety and tolerability of the anti-VEGF
(vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton
beam irradiation for the treatment of choroidal melanoma by determining the incidence and
severity of ocular adverse events. Systemic adverse events will also be evaluated. A
secondary objective is to assess the efficacy of ranibizumab in reducing ocular
complications that can occur after irradiation.
(vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton
beam irradiation for the treatment of choroidal melanoma by determining the incidence and
severity of ocular adverse events. Systemic adverse events will also be evaluated. A
secondary objective is to assess the efficacy of ranibizumab in reducing ocular
complications that can occur after irradiation.
Inclusion Criteria:
- Patients with newly diagnosed choroidal melanoma undergoing proton therapy
- Tumors >15 mm in largest diameter and/or >5 mm in height
- Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic
disc and/or macula, with 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
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