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Intravitreal Aflibercept Injection for Radiation Retinopathy

This study is currently recruiting participants.
Verified December 2012 by Washington University School of Medicine
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01579760
First received: April 10, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to assess the safety of intravitreal aflibercept injection - in the treatment of macular edema associated with retinopathy secondary to previous radiation therapy.


Condition Intervention Phase
Radiation Retinopathy
Macular Edema
 Drug: Aflibercept every 2 months
Drug: Aflibercept monthly
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treatment of Radiation Retinopathy With Intravitreal Aflibercept Injection 2.0mg

Resource links provided by NLM:

Drug Information available for: Aflibercept
U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Severity of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean change in best corrected visual acuity from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean change in central foveal thickness by optical coherence tomography (OCT) from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean central foveal thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients gaining 3 lines of vision [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean change in lesion characteristics (lesion size, leakage) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients with no fluid on OCT [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean change in macular volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aflibercept every 2 months Drug: Aflibercept every 2 months
2.0 mg aflibercept intravitreal injections once per month for the first 3 months (M0, M1, M2), then every 2 months (M4, M6, M8, M10)
Other Names:
  • EYLEA
  • VEGF Trap-Eye
Experimental: aflibercept monthly Drug: Aflibercept monthly
2.0mg aflibercept intravitreal injections every month (M0-11)
Other Names:
  • EYLEA
  • VEGF Trap-Eye

Detailed Description:

Radiation retinopathy can cause decreased vision in patients who have received either external beam radiation or local plaque therapy to the eye. An early manifestation of radiation retinopathy is macular edema, which represents fluid within the retina that affects central vision. There is currently no approved treatment for this disease, although there have been anecdotal reports of benefit with laser photocoagulation, intravitreal anti-VEGF agents, or intravitreal steroid use. This is a phase 1 study to evaluate aflibercept for the treatment of macular edema associated with retinopathy secondary to previous radiation treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Retinopathy associated with previous I-125 brachytherapy for uveal melanoma (85 Gy over 96 hours) at least 6 months prior to enrollment
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years
  • Center involved macular edema > 300µm in thickness on SD-OCT
  • Best corrected visual acuity of 20/40- 20/400
  • Birth control therapy for females of child-bearing age

Exclusion Criteria:

  • Pre-existing retinopathy due to other disorders
  • Vision decrease is considered to be due to ischemic radiation retinopathy without macular edema or optic neuropathy
  • Presence of metastasis
  • 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.
  • Prior enrollment in any study with intravitreal aflibercept injection
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
  • History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 4 months of study enrollment.
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 6-month study period
  • Presence of significant subfoveal fibrosis or atrophy
  • Intraocular surgery (including cataract surgery) in the study eye within 2 months of enrollment
  • Active intraocular inflammation (grade trace or above) in the study eye
  • History of allergy to fluorescein, ICG or iodine, not amenable to treatment
  • Prior/Concomitant Treatment:
  • Panretinal photocoagulation treatment
  • Previous intraocular steroids or PDT within 3 months
  • Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals)
  • Previous treatment with intravitreally (in either eye) or intravenously administered Avastin (bevacizumab) within 60 days or concomitant use in either eye outside the scope of this study
  • Previous use of Eylea, Macugen or Lucentis in study eye within 60 days or concomitant use in either eye outside the scope of this study
  • Prior submacular or vitreous surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579760

Contacts
Contact: Sam Pistorius, COA 314.747.5832 pistoriuss@vision.wustl.edu
Contact: Kimberly Hsu, MD 314.294.8022 hsuk@vision.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Regeneron Pharmaceuticals
Investigators
Principal Investigator: Rajendra Apte, MD, PhD Washington University School of Medicine
  More Information

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01579760     History of Changes
Other Study ID Numbers: aflibercept2012
Study First Received: April 10, 2012
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
radiation
retinopathy
macular edema
 anti-VEGF
VEGF-Trap
aflibercept

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Diseases
Signs and Symptoms
 Macular Degeneration
Retinal Degeneration
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013