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High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy

Primary Purpose

Radiation Retinopathy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ranibizumab 2.0 mg
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, anti-VEGF, eye

Eligibility Criteria

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

Inclusion Criteria

Subjects will be eligible if the following criteria are met:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 21 years
  • History of a clinical diagnosis of radiation retinopathy
  • Subjects who are at least 3 months and no more than 10 years from radiation therapy
  • History of prior treatment for radiation retinopathy with incomplete response (eg. persistent edema, presence of hemorrhage, presence of exudates, etc
  • ETDRS best corrected visual acuity of 20/400 or better in the study eye
  • Ability to return for all study visits

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from this study:

  • Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial
  • Subject with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
  • Subjects who have undergone intraocular surgery within last 60 days.
  • Subjects who have had intravitreal anti-VEGF treatment within 30 days.
  • Subjects who have had intravitreal triamcinolone acetonide within 4 months.
  • Subjects who have had laser within 60 days.
  • Inability to obtain photographs to document CNV (including difficulty with venous access).
  • Subject with known adverse reaction to fluorescein dye.
  • Subject 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.
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure >30 mm Hg despite treatment with anti-glaucoma medication)
  • Inability to comply with study or follow-up procedure

Sites / Locations

  • The New York Eye Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

With Loading Doses

Physician Discretion

Arm Description

5 patients will receive intravitreal injections every 30 days (+/- 7 days) for the first 4 months and every month thereafter until month 12 (maximum of 12 injections)

5 patients will receive intravitreal ranibizumab every 30 days (+/- 7 days) on as needed basis based on the criteria defined in the study.

Outcomes

Primary Outcome Measures

Number of participants with adverse events (allergy, infection, or change in vital signs)
All subjects will be assessed at baseline, at 7 days after first injection, and monthly for adverse events. The primary outcome measures for safety and tolerability are: 1. incidence and severity of ocular adverse events, as identified by eye examination (including best corrected visual acuity testing) and 2. Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs

Secondary Outcome Measures

Number of participants with changes in central foveal thickness
This secondary outcome measure will evaluate the effect of ranibizumab in both groups (arms) on Regression of radiation retinopathy as measured by mean change in central retinal thickness as measured on optical coherence tomography (OCT) compared to baseline
Number of participants with changes in visual acuity
Each month each subject will be tested for best corrected visual acuity as compared to baseline.
Number of injections each group (arm) has received
Each group (arm) will be assessed for the number of monthyl injections received through Month 12.
Number of participants with qualitative changes in retinopathy on ophthalmoscopy and fluorescein angiography
Evaluation of both arms on qualitative change in exudates, retinal hemorrhage, microaneurym and neovascularization) as seen on ophthalmoscopy/color photography and fluorescein angiography compared to baseline.

Full Information

First Posted
April 11, 2011
Last Updated
September 30, 2014
Sponsor
The New York Eye Cancer Center
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01334879
Brief Title
High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy
Official Title
High Dose (2.0mg) Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (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
Yes

5. Study Description

Brief Summary
This study investigates the use of a high dose anti-VEGF agent for the treatment of radiation retinopathy in those patients who have recalcitrant disease.
Detailed Description
This study is an open-label, Phase I study of intravitreally administered ranibizumab in subjects with radiation retinopathy. This is a single center, non-randomized, active treatment study involving 10 consecutive patients. This study will evaluate the safety and tolerability of a high dose (2.0 mg) intravitreal ranibizumab and its effect on regression of radiation retinopathy and mean change in visual acuity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Retinopathy
Keywords
radiation, retinopathy, anti-VEGF, eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With Loading Doses
Arm Type
Active Comparator
Arm Description
5 patients will receive intravitreal injections every 30 days (+/- 7 days) for the first 4 months and every month thereafter until month 12 (maximum of 12 injections)
Arm Title
Physician Discretion
Arm Type
Active Comparator
Arm Description
5 patients will receive intravitreal ranibizumab every 30 days (+/- 7 days) on as needed basis based on the criteria defined in the study.
Intervention Type
Drug
Intervention Name(s)
ranibizumab 2.0 mg
Other Intervention Name(s)
Lucentis
Intervention Description
Intravitreal ranibizumab (2.0 mg)
Primary Outcome Measure Information:
Title
Number of participants with adverse events (allergy, infection, or change in vital signs)
Description
All subjects will be assessed at baseline, at 7 days after first injection, and monthly for adverse events. The primary outcome measures for safety and tolerability are: 1. incidence and severity of ocular adverse events, as identified by eye examination (including best corrected visual acuity testing) and 2. Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs
Time Frame
Baseline, at day 7, then monthly
Secondary Outcome Measure Information:
Title
Number of participants with changes in central foveal thickness
Description
This secondary outcome measure will evaluate the effect of ranibizumab in both groups (arms) on Regression of radiation retinopathy as measured by mean change in central retinal thickness as measured on optical coherence tomography (OCT) compared to baseline
Time Frame
Monthly, Report at Month 12
Title
Number of participants with changes in visual acuity
Description
Each month each subject will be tested for best corrected visual acuity as compared to baseline.
Time Frame
Monthly, Report at Month 12
Title
Number of injections each group (arm) has received
Description
Each group (arm) will be assessed for the number of monthyl injections received through Month 12.
Time Frame
Monthly, Report at Month 12
Title
Number of participants with qualitative changes in retinopathy on ophthalmoscopy and fluorescein angiography
Description
Evaluation of both arms on qualitative change in exudates, retinal hemorrhage, microaneurym and neovascularization) as seen on ophthalmoscopy/color photography and fluorescein angiography compared to baseline.
Time Frame
Monthly Report at Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subjects will be eligible if the following criteria are met: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age > 21 years History of a clinical diagnosis of radiation retinopathy Subjects who are at least 3 months and no more than 10 years from radiation therapy History of prior treatment for radiation retinopathy with incomplete response (eg. persistent edema, presence of hemorrhage, presence of exudates, etc ETDRS best corrected visual acuity of 20/400 or better in the study eye Ability to return for all study visits Exclusion Criteria Subjects who meet any of the following criteria will be excluded from this study: Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated Participation in another simultaneous medical investigation or trial Subject with significantly compromised visual acuity in the study eye due to concomitant ocular conditions. Subjects who have undergone intraocular surgery within last 60 days. Subjects who have had intravitreal anti-VEGF treatment within 30 days. Subjects who have had intravitreal triamcinolone acetonide within 4 months. Subjects who have had laser within 60 days. Inability to obtain photographs to document CNV (including difficulty with venous access). Subject with known adverse reaction to fluorescein dye. Subject 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. Uncontrolled glaucoma in the study eye (defined as intraocular pressure >30 mm Hg despite treatment with anti-glaucoma medication) Inability to comply with study or follow-up procedure
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

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed?term=radiation%20retinopathy%20Finger%20PT
Description
Dr. Finger's Radiation Retinopathy Studies

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High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy

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