High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Paul T. Finger, MD, The New York Eye Cancer Center
ClinicalTrials.gov Identifier:
NCT01334879
First received: April 11, 2011
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Radiation Retinopathy
Drug: ranibizumab 2.0 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose (2.0mg) Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of participants with adverse events (allergy, infection, or change in vital signs) [ Time Frame: Baseline, at day 7, then monthly ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Monthly, Report at Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Monthly, Report at Month 12 ] [ Designated as safety issue: No ]
    Each month each subject will be tested for best corrected visual acuity as compared to baseline.

  • Number of injections each group (arm) has received [ Time Frame: Monthly, Report at Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Monthly Report at Month 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: May 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: With Loading Doses
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)
Drug: ranibizumab 2.0 mg
Intravitreal ranibizumab (2.0 mg)
Other Name: Lucentis
Active Comparator: Physician Discretion
5 patients will receive intravitreal ranibizumab every 30 days (+/- 7 days) on as needed basis based on the criteria defined in the study.
Drug: ranibizumab 2.0 mg
Intravitreal ranibizumab (2.0 mg)
Other Name: Lucentis

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334879

Locations
United States, New York
The New York Eye Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
The New York Eye Cancer Center
Genentech, Inc.
Investigators
Principal Investigator: Paul T Finger, MD The New York Eye Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Paul T. Finger, MD, Principal Investigator, The New York Eye Cancer Center
ClinicalTrials.gov Identifier: NCT01334879     History of Changes
Other Study ID Numbers: FVF4981S
Study First Received: April 11, 2011
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The New York Eye Cancer Center:
radiation
retinopathy
anti-VEGF
eye

Additional relevant MeSH terms:
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 20, 2014