Role of Intravitreal Aflibercept Injection for the Treatment of Radiation Maculopathy

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to assess the safety of intravitreal aflibercept injection in treating visually compromising radiation maculopathy secondary to treatment of uveal melanoma by iodione-125 brachytherapy. The study will consist of two arms of 25 patients each (totaling 50 patients). Subjects in arm 1 will undergo treatment every 6 weeks. Subjects in arm 2 will undergo treatment and if improvement is documented at the following evaluation the next treatment will be extended by two weeks. Secondary objectives of the study include evaluation and analysis of visual acuity, number of injections, macular edema, and vascular activity between both arms.

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

Details

• Lead Sponsor: Larkin Community Hospital
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

• A Patient must meet the following criteria to be eligible for inclusion in the study:

1. 21 years of age and over

2. 20/800 or better visual acuity

3. Must have received previous treatment for radiation maculopathy within the last 4-26 weeks

4. Any presence of macular edema (evaluated by SD-OCT) caused by radiation retinopathy

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

6. Provide signed informed consent

Exclusion Criteria:

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

1. Patients less than 21 years of age.

2. Patients with mental disability or any other condition that precludes the acquisition of an sdOCT image such as (nystagmus, neck disease, etc.)

3. Patients who have previously been treated with intravitreal triamcinolone acetonide for macular edema (signs of recalcitrant disease)