CT SPOTLIGHT

Settling the SCORE2

In a new study, two anti-VEGF drugs will be compared head to head to treat macular edema associated with CRVO.

ANDREW E. MATHIS, PhD, MANAGING EDITOR

Several treatments have received FDA approval to treat macular edema associated with central retinal vein occlusion in recent years. However, all of the available treatments have drawbacks: the approved anti-VEGF agents are expensive, and intravitreal steroids have known complications of increased intraocular pressure and cataracts.

Launched nearly a decade ago, the Standard Care vs COrticosteroid for REtinal Vein Occlusion (SCORE) study found that intravitreal triamcinolone acetonide (Kenalog, Alcon, Fort Worth, TX) was effective for the treatment of CRVO-associated macular edema.

Now, SCORE2 is set to enroll patients and will compare intravitreal bevacizumab (Avastin, Genentech, South San Francisco, CA) to aflibercept (Eylea, Tarrytown, NY) for the treatment of decreased vision due to macular edema associated with CRVO.

Ingrid U. Scott, MD, MPH, of Penn State College of Medicine, who is the study chair for SCORE2, told Retinal Physician about the trial.

COMPARING ANTI-VEGF DRUGS

Phase 3 clinical trials have demonstrated the efficacy of intravitreal triamcinolone, the intravitreal dexamethasone implant (Ozurdex, Allergan, Irvine, CA), intravitreal ranibizumab (Lucentis, Genentech), and intravitreal aflibercept in the management of macular edema associated with CRVO.

The safety and efficacy of intravitreal bevacizumab for the treatment of CRVO-associated macular edema have been reported in case reports and small, randomized trials. “None of these treatments has been compared head-to-head for the treatment of macular edema associated with CRVO, and there is a need for data to help clinicians select evidence-based first- and second-line therapies,” Dr. Scott says.

“The decision to compare aflibercept to bevacizumab and not to ranibizumab was dictated to some extent by cost,” Dr. Scott says. “Given that aflibercept and ranibizumab are similar in cost, and bevacizumab is substantially less expensive, if bevacizumab is demonstrated to be a noninferior treatment to aflibercept in SCORE2, this would have important economic and public health implications.”

DETAILS OF THE TRIAL

SCORE2 aims to randomize 360 patients in a 1:1 ratio to either 2.0 mg of aflibercept every four weeks or 1.25 mg of bevacizumab every four weeks, with primary outcomes to be assessed at six months.

The study will use visual acuity letter score and OCT-measured retinal thickness to evaluate the clinical efficacy of the drugs. At six months, patients who have demonstrated a good response to aflibercept or bevacizumab will be randomized to continue treatment with their originally assigned medication monthly vs a treat-and-extend dosing strategy.

“The treat-and-extend dosing strategy has been reported to be the most common intravitreal anti-VEGF dosing strategy employed by ophthalmologists in the United States. Therefore, it is important to investigate whether treat-and-extend outcomes are similar to outcomes achieved with monthly anti-VEGF therapy,” Dr. Scott says. RP