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

Primary Purpose

Radiation Retinopathy, Choroidal Melanoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
ranibizumab
Sponsored by
The New York Eye Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiation Retinopathy focused on measuring radiation, retinopathy, ranibizumab, melanoma, choroid

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The New York Eye Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravitreal ranibizumab

Arm Description

Patients will receive intravitreal ranibizumab on a monthly basis depending on response to treatment

Outcomes

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

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

Full Information

First Posted
September 9, 2008
Last Updated
April 25, 2012
Sponsor
The New York Eye Cancer Center
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00750399
Brief Title
Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma
Official Title
An Open Label Study to Evaluate the Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The New York Eye Cancer Center
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Retinopathy, Choroidal Melanoma
Keywords
radiation, retinopathy, ranibizumab, melanoma, choroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravitreal ranibizumab
Arm Type
Experimental
Arm Description
Patients will receive intravitreal ranibizumab on a monthly basis depending on response to treatment
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
intravitreal ranibizumab monthly for 4 months, and then every month thereafter until month 12.
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
intravitreal ranibizumab 0.5 mg
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul T Finger, MD
Organizational Affiliation
The New York Eye Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The New York Eye Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18313522
Citation
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.
Results Reference
background
PubMed Identifier
17562985
Citation
Finger PT, Chin K. Anti-vascular endothelial growth factor bevacizumab (avastin) for radiation retinopathy. Arch Ophthalmol. 2007 Jun;125(6):751-6. doi: 10.1001/archopht.125.6.751.
Results Reference
background
PubMed Identifier
20142553
Citation
Finger PT, Chin KJ. Intravitreous ranibizumab (lucentis) for radiation maculopathy. Arch Ophthalmol. 2010 Feb;128(2):249-52. doi: 10.1001/archophthalmol.2009.376. No abstract available.
Results Reference
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Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma

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