Intravitreal Aflibercept Injection for Radiation Retinopathy

Macular Edema Clinical Trial

Official title:

Treatment of Radiation Retinopathy With Intravitreal Aflibercept Injection 2.0mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579760
• Other study ID #: aflibercept2012
• Status: Completed
• Phase: Phase 1
• Start date: November 2012
• Est. completion date: March 27, 2019

Study information

• Verified date: April 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 27, 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Edema
• Radiation Retinopathy
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Retina Consultants of Houston	Houston	Texas
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (3)

Finger PT, Chin K. Anti-vascular endothelial growth factor bevacizumab (avastin) for radiation retinopathy. Arch Ophthalmol. 2007 Jun;125(6):751-6. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		12 months
Primary	Severity of adverse events		12 months
Secondary	Mean change in best corrected visual acuity from baseline		12 months
Secondary	Mean change in central foveal thickness by optical coherence tomography (OCT) from baseline		12 months
Secondary	Mean visual acuity		12 months
Secondary	Mean central foveal thickness		12 months
Secondary	Proportion of patients gaining 3 lines of vision		12 months
Secondary	Mean change in lesion characteristics (lesion size, leakage)		12 months
Secondary	Proportion of patients with no fluid on OCT		12 months
Secondary	Mean change in macular volume		12 months