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

This study is not yet open for participant recruitment.
Verified by The New York Eye Cancer Center, September 2008

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    Retinal Disorders   

ChemIDplus related topics:   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:   June 2010
Estimated Primary Completion Date:   June 2010 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Ranibizumab
    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     Not yet 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:

Responsible Party:   The New York Eye Cancer Center ( Paul T. Finger, MD )
Study ID Numbers:   FVF4519s
First Received:   September 9, 2008
Last Updated:   September 9, 2008
ClinicalTrials.gov Identifier:   NCT00750399
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
Neuroepithelioma
Nevus
Retinal Diseases
Melanoma of the choroid
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 06, 2008




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