Clinical trial · Interventional
Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Choroidal Melanoma | Choroid Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ranibizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1.0 mg ranibizumab
- description
- 1.0 mg intravitreal injection given bi-monthly for 22 months
- interventionNames
- Drug: ranibizumab
- type
- EXPERIMENTAL
- label
- 0.5 mg ranibizumab
- description
- 0.5 mg intravitreal injection given bi-monthly for 22 months
- interventionNames
- Drug: ranibizumab
Primary outcomes (1)
- measure
- incidence and severity of ocular adverse events and systemic adverse events
- timeFrame
- 12 months and 24 months after initial treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available