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Radiation RetinopathyPhase 1NCT01579760

Intravitreal Aflibercept Injection for Radiation Retinopathy

A Phase 1 study testing Aflibercept every 2 months and Aflibercept monthly in people with Radiation Retinopathy and Macular Edema, run by Washington University School of Medicine at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Radiation Retinopathy, Macular Edema
What is being tested?
Aflibercept every 2 months and Aflibercept monthly
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
2 sitesUnited States
Study dates
Nov 2012to 27 Mar 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Retina Consultants of Houston

    Houston, Texas, 77030

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Aflibercept every 2 months, Aflibercept monthly
Keywords
radiation, retinopathy, macular edema, anti-VEGF, VEGF-Trap, aflibercept
Medical subject headings
Macular Edema, Retinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aflibercept every 2 monthsDrug

    Also called EYLEA, VEGF Trap-Eye

    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)

  • Aflibercept monthlyDrug

    Also called EYLEA, VEGF Trap-Eye

    2.0mg aflibercept intravitreal injections every month (M0-11)

Study groups in NCT01579760
Study groupRoleWhat they receive
aflibercept every 2 monthsExperimentalNot described
Receives: Drug: Aflibercept every 2 months
aflibercept monthlyExperimentalNot described
Receives: Drug: Aflibercept monthly

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Measured: 12 months

  2. Severity of adverse events

    Measured: 12 months

Secondary outcomes (8)

  1. Mean change in best corrected visual acuity from baseline

    Measured: 12 months

  2. Mean change in central foveal thickness by optical coherence tomography (OCT) from baseline

    Measured: 12 months

  3. Mean visual acuity

    Measured: 12 months

  4. Mean central foveal thickness

    Measured: 12 months

  5. Proportion of patients gaining 3 lines of vision

    Measured: 12 months

  6. Mean change in lesion characteristics (lesion size, leakage)

    Measured: 12 months

  7. Proportion of patients with no fluid on OCT

    Measured: 12 months

  8. Mean change in macular volume

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionJan 2019
  4. Study completion27 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01579760
Sponsor's protocol ID
aflibercept2012
Status last verified
Apr 2019
First submitted
10 Apr 2012
Last updated
25 Apr 2019
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 18301032

  • 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.

    PubMed 17562985

  • 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.

    PubMed 19349865

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Aflibercept every 2 months and Aflibercept monthly in people with Radiation Retinopathy and Macular Edema, run by Washington University School of Medicine at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01579760, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.

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