Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma - Full Text View

Sponsors and Collaborators:	The New York Eye Cancer Center Genentech
Information provided by:	The New York Eye Cancer Center
ClinicalTrials.gov Identifier:	NCT00750399

Purpose

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.

Condition	Intervention	Phase
Radiation Retinopathy Choroidal Melanoma	Drug: Ranibizumab	Phase I

MedlinePlus related topics: Cancer Eye Cancer Melanoma Radiation Therapy Retinal Disorders

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Study to Evaluate the Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma

Further study details as provided by The New York Eye Cancer Center:

Primary Outcome Measures:

To test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy associated with plaque brachytherapy for choroidal melanoma [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the efficacy of intravitreal ranibizumab on treating radiation retinopathy following plaque brachytherapy for choroidal melanoma, and effect on visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	October 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

intravitreal ranibizumab monthly for 4 months, and then every month thereafter until month 12.

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

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750399

Contacts

Contact: Kimberly Chin, OD	212.832.7297	kchin@eyecancer.com
Contact: Paul T Finger, MD	212.832.7297	pfinger@eyecancer.com

Locations

United States, New York
The New York Eye Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Paul T Finger, MD 212-832-8170 pfinger@eyecancer.com
Contact: Lindsey Marabella 212.832.8170 llafferty@eyecancer.com
Principal Investigator: Paul T Finger, MD, MD
Sub-Investigator: Kimberly Chin, OD

Sponsors and Collaborators

The New York Eye Cancer Center

Genentech

Investigators

Principal Investigator:

Paul T Finger, MD

The New York Eye Cancer Center

More Information

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.

Finger PT, Chin K. Anti-vascular endothelial growth factor bevacizumab (avastin) for radiation retinopathy. Arch Ophthalmol. 2007 Jun;125(6):751-6.

Responsible Party:	The New York Eye Cancer Center ( Paul T. Finger, MD )
Study ID Numbers:	FVF4519s
Study First Received:	September 9, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00750399 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by The New York Eye Cancer Center:

radiation
retinopathy
ranibizumab
melanoma
choroid

Study placed in the following topic categories:

Neuroectodermal Tumors
Eye Diseases
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Melanoma of the Choroid

Neuroepithelioma
Nevus
Retinal Diseases
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Eye Diseases
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Retinal Diseases
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on May 07, 2009