Intravitreal Aflibercept Injection for Radiation Retinopathy

The Washington University

Status and phase

Completed

Phase 1

Conditions

Macular Edema

Radiation Retinopathy

Treatments

Drug: Aflibercept monthly

Drug: Aflibercept every 2 months

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01579760

aflibercept2012

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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