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Two studies test efficacy of VEGF Trap-Eye treatment
The multicenter, international studies are evaluating the potential treatment for macular edema secondary to central retinal vein occlusion.
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 Frank G. Holz |
PARIS — The GALILEO and COPERNICO studies are currently evaluating the efficacy of VEGF Trap-Eye in the treatment of macular edema secondary to central retinal vein occlusion, according to a clinician.
The two phase 3 studies, led by Bayer and Regeneron, are similar in design and represent an international, multicenter effort. The studies involve 134 study locations in 14 countries in the Americas, Asia, Europe and Oceania. Enrollment was recently completed.
Results from both studies are expected in early 2011, according to Frank G. Holz, MD.
At the Euretina meeting, Dr. Holz said that VEGF Trap-Eye is a novel investigational therapy using anti-VEGF “with high binding affinity for VEGF-A and placental growth factor. Both VEGF-A and PLGF are proteins that are involved in the abnormal growth of new blood vessels.”
“It is believed that anti-VEGF treatment may help decrease vascular permeability and edema and prevent the growth of abnormal new blood vessels in the retina in patients with CRVO,” Dr. Holz said. “The edema resulting from CRVO is driven in part by increased intraocular expression of VEGF and has already been shown to respond positively to anti-VEGF therapy with ranibizumab.”
Study design
In both studies, patients who are randomized to receive the active treatment are administered 2 mg of VEGF Trap-Eye every 4 weeks for 24 weeks. An as-needed regimen is then adopted for 1 year. The control group receives sham injection for 52 weeks in the GALILEO study and for 24 weeks in the COPERNICO study, then switches to active therapy until endpoint at weeks 76 and 100, respectively.
Panretinal photocoagulation is available if patients develop anterior or posterior segment neovascularization.
 Central vein occlusion. Image: Holz FG |
“Primary endpoint will be the proportion of patients who gain at least 15 letters (three or more lines) in BCVA at week 24 compared to baseline. There are secondary endpoints, including change in central retinal thickness assessed by OCT at 24 weeks, proportion of patients progressing to neovascularization and subjectively reported lifestyle and vision changes,” Dr. Holz said.
About disease
Retinal vein occlusion is the second most common retinal vascular disease, following diabetic retinopathy. It is a highly prevalent problem and a significant clinical cause for severe visual loss. Leakage in the macula leads to the development of secondary macular edema.
About one-third of patients progress to the ischemic type of the disease, with further problems from new vessel growth.
“The rationale for using anti-VEGF therapy in [macular edema] secondary to CRVO is strong, and the VEGF Trap-Eye may demonstrate superior efficacy,” Dr. Holz said. – by Michela Cimberle
- Frank G. Holz, MD, can be reached at University of Bonn, Ernst-Abbe-Strasse 2, D-53105 Bonn, Germany; +49 22828715647; fax +49 22828715603; e-mail: Frank.Holz@ukb.uni-bonn.de.
- Disclosure: Dr. Holz is a consultant for Bayer, Genentech, Novartis and Pfizer.