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Evaluation of pain and inflammation after injection of ranibizumab vs. aflibercept for treatment of wet AMD
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Institution: Sierra Eye Associates, Reno, Nev.
Author/principal investigator: Arshad Khanani, MD
Abstract/statement of the trial’s goals
This is an open-label phase 1/2 study of post- injection pain and inflammation after intravitreally administered Lucentis (ranibizumab, Genentech) and Eylea (aflibercept, Regeneron) in 100 subjects with neovascular age-related macular degeneration. We will enroll both treatment-experienced patients (patients who were treated with ranibizumab or aflibercept but not Avastin [bevacizumab, Genentech] in the past) and treatment-naïve patients (new-onset neovascular AMD with no history of intravitreal injections). The treatment-experienced patients will be treated with the intravitreal medication other than what they were receiving in the past; for example, patients treated with ranibizumab will switch to aflibercept for study purposes and vice versa.
Consented, enrolled subjects will receive open-label intravitreal injection of either 0.5 mg ranibizumab or 2 mg aflibercept. A standard intravitreal injection protocol will be followed. Patients will be re-evaluated between 24 to 48 hours and 5 to 7 days after injections. A non-injecting physician will evaluate the patients for anterior chamber inflammation; this physician will be blinded about the specific treatment. Anterior chamber inflammation is described as any cell or flare in the anterior chamber. These will be evaluated using Standardization of Uveitis Nomenclature working group classifications.
Study population: 100
Inclusion criteria
- Able to provide informed consent and comply with study assessments for the full duration of the study.
- 65 years of age or older.
- New-onset neovascular AMD.
- Previously treated neovascular AMD with ranibizumab or aflibercept intravitreal injections.
- Visual acuity of 20/400 or better.
- No history of post-injection pain or inflammation with prior treatments.
Exclusion criteria
- History of endophthalmitis in either eye.
- Uncontrolled or symptomatic dry eye syndrome.
- History of anterior or posterior uveitis.
- History of post-injection pain or inflammation with prior treatments.
- Recent thromboembolic event (less than 3 months).
- Pregnancy or lactation/premenopausal women not using adequate contraception.
Enrollment status: Actively enrolling.