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”

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).

Study Type: Interventional

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

Study Primary Completion Date: February 2009

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.

Intervention(s) in this Clinical Trial

• Drug: intravitreal triamcinolone injection
  • 4 mg dose
• Drug: intravitreal triamcinolone injection
  • 1 mg dose

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • CRVO 4 mg dose vs Standard of Care
• Active Comparator: 2
  • CRVO 1 mg dose vs Standard of Care
• Active Comparator: 3
  • CRVO 4 mg dose vs 1 mg dose
• Active Comparator: 4
  • BRVO 4 mg dose vs Standard of Care
• Active Comparator: 5
  • BRVO 1 mg dose vs Standard of Care
• Active Comparator: 6
  • BRVO 4 mg dose vs 1 mg dose

Primary Measures

• Improvement by 15 or more letters from baseline in best-corrected ETDRS visual acuity score at the 12-month visit
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• Changes from baseline in best-corrected ETDRS visual acuity score
  • Time Frame: 36 months
    Safety Issue?: No
• Changes in retinal thickness as assessed by stereoscopic color fundus photography and optical coherence tomography
  • Time Frame: 36 months
    Safety Issue?: No
• Adverse ocular outcomes
  • Time Frame: 36 months
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Allergan

Overall Clinical Trial Officials and Contacts

Michael S. Ip, M.D. Study Chair University of Wisconsin, Madison  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00105027

Study ID Number: NEI-99

ClinicalTrials.gov Identifier: NCT00105027

Health Authority: United States: Federal Government

SCORE Study website

NEI Clinical Studies Database