Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Diagnostic, Supportive care Approved-not yet active 21 and over Other, Pharmaceutical / Industry FVF4519s NCT00750399

Trial Description

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.

Further Study Information

Following plaque brachytherapy as treatment for choroidal melanoma, patients may develop radiation retinopathy. Radiation retinopathy is a progressive condition that leads to blindness in over 50% of cases within 5 years of treatment.

Vascular endothelial growth factor (VEGF) protein is believed to play a critical role in angiogenesis and radiation retinopathy. It is one of the key contributors to physiological or pathological conditions that can stimulate both the formation of new blood vessels and normal vessel incompetence. Ranibizumab is a recently approved vascular endothelial growth factor (VEGF) inhibitor shown to be effective in treating exudative macular degeneration. Ranibizumab binds to and inhibits vascular endothelial growth factor A (VEGF-A), which has been shown to cause neovascularization and leakage in models of ocular angiogenesis.

This is an open label, non-randomized active treatment, Phase I trial to assess the safety and tolerability of intravitreal ranibizumab and its ability to reduce radiation retinopathy and potentially limit vision loss associated with this disease.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

New York Eye Cancer Center

Paul T. Finger

Principal Investigator

Kimberly Chin, OD		Ph: 212.832.7297
		Email: kchin@eyecancer.com

Paul T. Finger		Ph: 212.832.7297
		Email: pfinger@eyecancer.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00750399
Information obtained from ClinicalTrials.gov on September 10, 2008