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

This study is currently recruiting patients.

Sponsored by: National Eye Institute (NEI)
Information provided by: National Eye Institute (NEI)

Purpose

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).

Condition Treatment or Intervention Phase
Macular Edema, Cystoid
Retinal Vein Occlusion
 Drug: intravitreal triamcinolone injection
Phase III

MedlinePlus related topics:  Macular Degeneration;   Retinal Disorders;   Vascular Diseases

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

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

Further Study Details: 
Primary Outcomes: Improvement by 15 or more letters from baseline in best-corrected ETDRS visual acuity score at the 12-month visit
Secondary Outcomes: 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
Expected Total Enrollment:  1260

Study start: October 2004;  Expected completion: October 2007
Last follow-up: November 2004;  Data entry closure: November 2004

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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.

Location and Contact Information

Michael S. Ip, M.D.      608-263-2853 
Ingrid U. Scott, M.D.      305-326-6447 

Wisconsin
      University of Wisconsin, Madison,  Wisconsin,  53711,  United States; Recruiting
Michael S. Ip, M.D.  608-263-2853 
Nancy Cahill  608-263-2853    cahill@rc.ophth.wisc.edu 

More Information

Study ID Numbers:  NEI-99
Record last reviewed:  March 2005
Last Updated:  March 3, 2005
Record first received:  March 3, 2005
ClinicalTrials.gov Identifier:  NCT00105027
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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