Intravitreal Aflibercept Injection for Radiation Retinopathy Trial

• Status: Active, not recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The ARRT trial will assess the safety and efficacy of 2mg aflibercept for the treatment of radiation retinopathy, including maculopathy and optic neuropathy over 52 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amy C Schefler, MD
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

1. Age > 18 years of age

2. Clinically identifiable radiation retinopathy with evidence of fluid on SD-OCT causing vision loss in the study eye

3. Undergone either ocular or orbital radiation for any primary ocular or orbital cancer within clinical evidence of having radiation retinopathy

4. Willing and able to comply with clinic visits and study-related procedures

5. Provide signed informed consent

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

1. Metastatic cancer or any active primary cancer, at time of enrollment

2. Prior treatment with anti VEGF in the study within 60 days of screen in the study eye

3. Prior intravitreal or subconjunctival treatment with cortical steroids within 90 days of screen in the study eye

4. Macular ischemia (defined as greater than 5 disc areas), as assessed by the investigator

5. Media opacity obscuring a view of the fundus or any other reason for vision loss other than radiation retinopathy.

6. Evidence of infectious ocular infection, in the study eye, at time of screening

7. Pregnant or breast-feeding women

8. Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception start of the first treatment, during the study, and for at least 3 months after the last dose. Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly.

• Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.