drugset / Trial / NCT02586727
Role of Intravitreal Aflibercept Injection for the Treatment of Radiation Maculopathy
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-10
- Primary completion
- 2018-12
- Completion
- 2020-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aflibercept | Protein / enzyme biologic | — | Intravitreal |