Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma
Information source: The New York Eye Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Radiation Retinopathy; Choroidal Melanoma
Intervention: Ranibizumab (Drug); ranibizumab (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: The New York Eye Cancer Center Official(s) and/or principal investigator(s): Paul T Finger, MD, Principal Investigator, Affiliation: The New York Eye Cancer Center
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.
Clinical Details
Official title: An Open Label Study to Evaluate the Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy associated with plaque brachytherapy for choroidal melanoma
Secondary outcome: To assess the efficacy of intravitreal ranibizumab on treating radiation retinopathy following plaque brachytherapy for choroidal melanoma, and effect on visual acuity
Detailed description:
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
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
The New York Eye Cancer Center, New York, New York 10065, United States
Additional Information
Related publications: Finger PT. Radiation retinopathy is treatable with anti-vascular endothelial growth factor bevacizumab (Avastin). Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):974-7. doi: 10.1016/j.ijrobp.2007.11.045. Finger PT, Chin K. Anti-vascular endothelial growth factor bevacizumab (avastin) for radiation retinopathy. Arch Ophthalmol. 2007 Jun;125(6):751-6.
Starting date: October 2008
Last updated: April 25, 2012
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