Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I clinical trial to test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy following plaque brachytherapy for patients with choroidal melanoma using the incidence and severity of events criteria.

The secondary objective is to assess the efficacy of intravitreal ranibizumab on regression of radiation retinopathy by ophthalmic examination, fundus photography, fluorescein angiography, and optical coherence tomography, as well as visual acuity.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The New York Eye Cancer Center
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Diagnosis of radiation retinopathy

• History of choroidal melanoma status post plaque brachytherapy

• Age > 21 years

• Ability to perform written consent and comply with study assessments for the full duration of the study

Exclusion Criteria:

• Pregnancy or lactation, pre-menopausal women not using contraception

• Participation in another simultaneous medical investigation or trial

• Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.

• Patients who have undergone intraocular surgery within last 60 days.

• Patients who have had intravitreal anti-VEGF treatment within 45 days.

• Patients who have had intravitreal triamcinolone acetonide within 4 months.

• Patients who have had laser within 60 days.

• Inability to obtain photographs to document CNV (including difficulty with venous access).

• Patient has a history of any medical condition which would preclude scheduled visits or completion of study.

• Aphakia or absence of the posterior capsule in the study eye. Previous violation of the posterior capsule in the study eye is also excluded unless as a result of yttrium aluminum garnet (YAG) posterior capsulotomy in association with posterior chamber lens implantation..

• History of glaucoma filtering surgery in the study eye.

• Concurrent use of more than two therapies for glaucoma.

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated