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Study to compare treatments for macular edema in BRVO
The COMO study is designed to assess improvement in best corrected visual acuity from baseline to 12 months in patients with disease duration of less than 90 days.
 Francesco Bandello |
Clinicians in Europe and Israel have embarked on the first head-to-head trial comparing a corticosteroid implant to an anti-VEGF injection for macular edema associated with branch retinal vein occlusion.
The multicenter, randomized COMO (Comparison of intravitreal dexamethasone implant and ranibizumab for macular edema in BRVO) study will compare the relative effectiveness of Ozurdex (dexamethasone 0.7 mg intravitreal implant, Allergan) with that of Lucentis (ranibizumab, Genentech/Novartis).
The study includes patients from 36 sites, according to a news release from the European arm of Allergan.
The GENEVA trial showed that a single injection of dexamethasone improved visual acuity for up to 6 months. The BRAVO trial showed ranibizumab to be effective in improving visual acuity in patients with a short duration of macular edema associated with branch retinal vein occlusion.
Francesco Bandello, MD, FEBO, the lead investigator for COMO, noted that the GENEVA and BRAVO studies had different inclusion criteria in terms of duration of retinal vein occlusion. Thus, the results of those studies cannot be used to make a reliable comparison of the two agents in terms of efficacy, Dr. Bandello said in an interview with Ocular Surgery News.
“This is the main reason why the company considered it important to make a head-to-head trial in order to see if there really is a difference among different approaches,” Dr. Bandello said. “I think there is some rationale for that. It’s a critical thing for giving us an instrument to know which is the best way of treating patients.”
Study design
The 12-month study includes approximately 400 patients at about 10 centers, Dr. Bandello said.
According to the release, the main requirement for patient inclusion is duration of macular edema following branch retinal vein occlusion of less than 90 days.
Dr. Bandello noted that more restricted inclusion and exclusion criteria would limit patient selection and hinder the application of study results to clinical practice.
“We try to have a specific limitation regarding the duration of the disease, which is the most important driver for the results,” Dr. Bandello said. “That’s the reason why the study was done. After that, there is no specific limitation. I think that’s the right way to go. Otherwise, you have results that are not easy to transfer to clinical practice. You can never understand how these results are applicable to your practice.”
Patients are randomized to receive dexamethasone or ranibizumab. Those receiving dexamethasone undergo an intravitreal injection on day 1 and at 5 months and 10 or 11 months, as needed.
Patients receiving ranibizumab undergo six injections on a monthly basis from day 1 to 6 months, then on an as-needed basis from 6 months to 11 months.
Endpoints
The study’s primary endpoint will be mean change in best corrected visual acuity from baseline to 12 months.
Investigators will also assess optical coherence tomography images and fluorescein angiography, Dr. Bandello said.
Fluorescein angiography will likely be performed at the beginning and end of the study. Such an approach will enable comprehensive assessment of anatomic changes, Dr. Bandello said.
“Some of the results from the GENEVA study are difficult to interpret because we do not understand where things were bad and where things were good,” he said. “It’s important to understand why you are having that specific result. If you don’t have a study that is able to show you microvasculature, it’s difficult to understand.” – by Matt Hasson
For more information:
Francesco Bandello, MD, FEBO, can be reached at Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele, Via Olgettina, 60 Milano 20132, Italy; +39-02-26432648; fax: +39-02-26433643; email: bandello.francesco@hsr.it.
Disclosure: Dr. Bandello serves as an advisory board member for Alcon, Allergan, Bausch + Lomb, Bayer, Genentech, Novartis, Pfizer and Thea.