- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01579760
Intravitreal Aflibercept Injection for Radiation Retinopathy
April 24, 2019 updated by: Washington University School of Medicine
Treatment of Radiation Retinopathy With Intravitreal Aflibercept Injection 2.0mg
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Texas
-
Houston, Texas, United States, 77030
- Retina Consultants of Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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:
|
EXPERIMENTAL: aflibercept monthly
|
2.0mg aflibercept intravitreal injections every month (M0-11)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events
Time Frame: 12 months
|
12 months
|
Severity of adverse events
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change in best corrected visual acuity from baseline
Time Frame: 12 months
|
12 months
|
Mean change in central foveal thickness by optical coherence tomography (OCT) from baseline
Time Frame: 12 months
|
12 months
|
Mean visual acuity
Time Frame: 12 months
|
12 months
|
Mean central foveal thickness
Time Frame: 12 months
|
12 months
|
Proportion of patients gaining 3 lines of vision
Time Frame: 12 months
|
12 months
|
Mean change in lesion characteristics (lesion size, leakage)
Time Frame: 12 months
|
12 months
|
Proportion of patients with no fluid on OCT
Time Frame: 12 months
|
12 months
|
Mean change in macular volume
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Prabakar K Rao, MD, Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Horgan N, Shields CL, Mashayekhi A, Teixeira LF, Materin MA, Shields JA. Early macular morphological changes following plaque radiotherapy for uveal melanoma. Retina. 2008 Feb;28(2):263-73. doi: 10.1097/IAE.0b013e31814b1b75.
- 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.
- Wen JC, McCannel TA. Treatment of radiation retinopathy following plaque brachytherapy for choroidal melanoma. Curr Opin Ophthalmol. 2009 May;20(3):200-4. doi: 10.1097/ICU.0b013e328329b62d.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (ACTUAL)
January 1, 2019
Study Completion (ACTUAL)
March 27, 2019
Study Registration Dates
First Submitted
April 10, 2012
First Submitted That Met QC Criteria
April 17, 2012
First Posted (ESTIMATE)
April 18, 2012
Study Record Updates
Last Update Posted (ACTUAL)
April 25, 2019
Last Update Submitted That Met QC Criteria
April 24, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- aflibercept2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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