Intravitreal Aflibercept Injection for Radiation Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01579760
Recruitment Status : Active, not recruiting
First Posted : April 18, 2012
Last Update Posted : May 1, 2018
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Radiation Retinopathy Macular Edema Drug: Aflibercept every 2 months Drug: Aflibercept monthly Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Radiation Retinopathy With Intravitreal Aflibercept Injection 2.0mg
Study Start Date : November 2012
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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:
  • VEGF Trap-Eye

Experimental: aflibercept monthly Drug: Aflibercept monthly
2.0mg aflibercept intravitreal injections every month (M0-11)
Other Names:
  • VEGF Trap-Eye

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 12 months ]
  2. Severity of adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mean change in best corrected visual acuity from baseline [ Time Frame: 12 months ]
  2. Mean change in central foveal thickness by optical coherence tomography (OCT) from baseline [ Time Frame: 12 months ]
  3. Mean visual acuity [ Time Frame: 12 months ]
  4. Mean central foveal thickness [ Time Frame: 12 months ]
  5. Proportion of patients gaining 3 lines of vision [ Time Frame: 12 months ]
  6. Mean change in lesion characteristics (lesion size, leakage) [ Time Frame: 12 months ]
  7. Proportion of patients with no fluid on OCT [ Time Frame: 12 months ]
  8. Mean change in macular volume [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01579760

United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Texas
Retina Consultants of Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Washington University School of Medicine
Regeneron Pharmaceuticals
Principal Investigator: Prabakar K Rao, MD Washington University School of Medicine

Responsible Party: Washington University School of Medicine Identifier: NCT01579760     History of Changes
Other Study ID Numbers: aflibercept2012
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by Washington University School of Medicine:
macular edema

Additional relevant MeSH terms:
Macular Edema
Retinal Diseases
Macular Degeneration
Retinal Degeneration
Eye Diseases