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

May 31, 2018 updated by: The Emmes Company, LLC

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

682

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53711
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: intravitreal triamcinolone injection
4 mg
Active Comparator: CRVO 4 mg dose triamcinolone acetonide
Drug: intravitreal triamcinolone injection
1 mg dose
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
Drug: intravitreal triamcinolone injection
4 mg
Active Comparator: BRVO 4 mg dose triamcinolone acetonide
Drug: intravitreal triamcinolone injection
1 mg dose
Drug: intravitreal triamcinolone injection
4 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Change from baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes From Baseline in Best-corrected ETDRS Visual Acuity Score
Time Frame: 12 months
12 months
Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography
Time Frame: 12 months
12 months
Adverse Ocular Outcomes
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Emmes Company, LLC

Collaborators

National Eye Institute (NEI)
Allergan

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (Estimate)

March 4, 2005

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEI-99
  • 5U10EY014351-05 (U.S. NIH Grant/Contract)
  • 5U10EY014404 (U.S. NIH Grant/Contract)
  • 5U10EY014352 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data sets will be provided to qualified investigators under a Data Use Agreement.

IPD Sharing Time Frame

to be set forth in data use agreement

IPD Sharing Access Criteria

qualified investigators

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Retinal Vein Occlusion

Clinical Trials on Standard Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe