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

This study has been completed.
Sponsor:
Collaborators:
Allergan
Information provided by (Responsible Party):
The EMMES Corporation
ClinicalTrials.gov Identifier:
NCT00105027
First received: March 3, 2005
Last updated: July 9, 2012
Last verified: July 2012

March 3, 2005
July 9, 2012
October 2004
February 2009   (final data collection date for primary outcome measure)
The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit [ Time Frame: Change from baseline to 12 months ] [ Designated as safety issue: No ]
Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart.
Improvement by 15 or more letters from baseline in best-corrected ETDRS visual acuity score at the 12-month visit
Complete list of historical versions of study NCT00105027 on ClinicalTrials.gov Archive Site
  • Changes From Baseline in Best-corrected ETDRS Visual Acuity Score [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Adverse Ocular Outcomes [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • 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
Not Provided
Not Provided
 
The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Macular Edema, Cystoid
  • Retinal Vein Occlusion
  • Other: Standard Care
    CRVO: observation; BRVO: standard care
  • Drug: intravitreal triamcinolone injection
    1 mg dose
  • Drug: intravitreal triamcinolone injection
    4 mg
  • Active Comparator: CRVO Observation
    Intervention: Other: Standard Care
  • Active Comparator: CRVO 1 mg dose triamcinolone acetonide
    Intervention: Drug: intravitreal triamcinolone injection
  • Active Comparator: CRVO 4 mg dose triamcinolone acetonide
    Intervention: Drug: intravitreal triamcinolone injection
  • Active Comparator: BRVO standard care
    Intervention: Other: Standard Care
  • Active Comparator: BRVO 1 mg dose triamcinolone acetonide
    Intervention: Drug: intravitreal triamcinolone injection
  • Active Comparator: BRVO 4 mg dose triamcinolone acetonide
    Intervention: Drug: intravitreal triamcinolone injection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
682
February 2009
February 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00105027
NEI-99, 5U10EY014351-05, 5U10EY014404, 5U10EY014352
Yes
The EMMES Corporation
The EMMES Corporation
  • National Eye Institute (NEI)
  • Allergan
Study Chair: Michael S. Ip, M.D. University of Wisconsin, Madison
The EMMES Corporation
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP