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
  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 Intervention Phase
Macular Edema, Cystoid
Retinal Vein Occlusion
Other: Standard Care
Drug: intravitreal triamcinolone injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by The EMMES Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 682
Study Start Date: October 2004
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CRVO Observation Other: Standard Care
CRVO: observation; BRVO: standard care
Active Comparator: CRVO 1 mg dose triamcinolone acetonide Drug: intravitreal triamcinolone injection
1 mg dose
Active Comparator: CRVO 4 mg dose triamcinolone acetonide Drug: intravitreal triamcinolone injection
4 mg
Active Comparator: BRVO standard care Other: Standard Care
CRVO: observation; BRVO: standard care
Active Comparator: BRVO 1 mg dose triamcinolone acetonide Drug: intravitreal triamcinolone injection
1 mg dose
Active Comparator: BRVO 4 mg dose triamcinolone acetonide Drug: intravitreal triamcinolone injection
4 mg

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105027

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
The EMMES Corporation
Allergan
Investigators
Study Chair: Michael S. Ip, M.D. University of Wisconsin, Madison
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The EMMES Corporation
ClinicalTrials.gov Identifier: NCT00105027     History of Changes
Other Study ID Numbers: NEI-99, 5U10EY014351-05, 5U10EY014404, 5U10EY014352
Study First Received: March 3, 2005
Results First Received: November 9, 2010
Last Updated: July 9, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by The EMMES Corporation:
macular edema
central retinal vein occlusion (CRVO)
branch retinal vein occlusion (BRVO)

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014