The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study

Macular edema is a major cause of vision loss in patients with CRVO and BRVO. Both CRVO and
BRVO are common retinal problems and are caused by a blockage in one of the large retinal
veins (central retinal vein occlusion - CRVO) or smaller retinal veins (branch retinal vein
occlusion - BRVO). Currently, there is no effective treatment for macular edema associated
with CRVO and standard care treatment is observation. Grid laser photocoagulation may be
effective for some patients for macular edema associated with BRVO, but many patients derive
limited benefit from this treatment. Therefore, the development of new treatment modalities
for macular edema caused by these two conditions is an important research goal.

Over the last several years, many patients with macular edema from CRVO and BRVO have been
treated with an injection of a type of steroid called triamcinolone directly into the eye.
This type of injection is called an intravitreal injection. The triamcinolone preparation
commonly injected into the eye is Kenalog and is FDA-approved only for use in muscles and
joints. The SCORE Study will use a formulation of triamcinolone made specifically for the
eye.

The SCORE Study is a multicenter, randomized, Phase III trial to compare the effectiveness
and safety of standard care versus triamcinolone injection(s) for the treatment of macular
edema associated with CRVO and BRVO. In each of the two disease areas, 630 participants will
be randomized (similar to a flip of a coin) in a 1:1:1 ratio to one of three groups: standard
care, intravitreal triamcinolone 4 mg, or intravitreal triamcinolone 1 mg. After
randomization, participants will be examined every 4 months through 3 years to collect
ophthalmic information, including visual acuity, intraocular pressure, optical coherence
tomography, and fundus photography . Fluorescein angiography will be performed at 4, 12 and
24 months. Repeat intravitreal injections of triamcinolone and repeat laser treatment will be
provided as clinically indicated based on protocol-specific guidelines.

The primary outcome is improvement by 15 or more letters from baseline in best-corrected
ETDRS visual acuity score at the 12-month visit. Secondary outcomes include changes from
baseline in best-corrected ETDRS visual acuity score, changes in retinal thickness as
assessed by stereoscopic color fundus photography and optical coherence tomography, and
adverse ocular outcomes.

Inclusion Criteria:

- Participants with macular edema (swelling of the central part of the retina)
associated with central retinal vein occlusion (CRVO) and branch retinal vein
occlusion (BRVO).

- Individuals, 18 years of age or older, willing to provide consent may be eligible for
the SCORE Study.

Exclusion Criteria: refer to SCORE Study website at https://web.emmes.com/study/score/ for
listing.