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

Condition(s) targeted: Macular Edema, Cystoid; Retinal Vein Occlusion

Intervention: intravitreal triamcinolone injection (Drug); intravitreal triamcinolone injection (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Michael S. Ip, M.D., Study Chair, Affiliation: University of Wisconsin, Madison

The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).

Official title: The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study: Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide With Standard Care to Treat Macular Edema

Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

Primary outcome: Improvement by 15 or more letters from baseline in best-corrected ETDRS visual acuity score at the 12-month visit

Secondary outcome:

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

Adverse ocular outcomes

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

University of Wisconsin, Madison, Wisconsin 53711, United States

SCORE Study website

NEI Clinical Studies Database

Related publications:

Bhavsar AR, Ip MS, Glassman AR; DRCRnet and the SCORE Study Groups. The risk of endophthalmitis following intravitreal triamcinolone injection in the DRCRnet and SCORE clinical trials. Am J Ophthalmol. 2007 Sep;144(3):454-6.

Starting date: October 2004
Ending date: February 2009
Last updated: March 17, 2008