NCT00105027

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
682

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 19, 2011

Completed
Last Updated

July 2, 2018

Status Verified

May 1, 2018

Enrollment Period

4.3 years

First QC Date

March 3, 2005

Results QC Date

November 9, 2010

Last Update Submit

May 31, 2018

Conditions

Macular Edema, CystoidRetinal Vein Occlusion

Keywords

macular edemacentral retinal vein occlusion (CRVO)branch retinal vein occlusion (BRVO)

Outcome Measures

Primary Outcomes (1)

  • 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

    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 Outcomes (3)

  • Changes From Baseline in Best-corrected ETDRS Visual Acuity Score

    12 months

  • Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography

    12 months

  • Adverse Ocular Outcomes

    12 months

Study Arms (6)

CRVO Observation

ACTIVE COMPARATOR
Other: Standard Care

CRVO 1 mg dose triamcinolone acetonide

ACTIVE COMPARATOR
Drug: intravitreal triamcinolone injection

CRVO 4 mg dose triamcinolone acetonide

ACTIVE COMPARATOR
Drug: intravitreal triamcinolone injection

BRVO standard care

ACTIVE COMPARATOR
Other: Standard Care

BRVO 1 mg dose triamcinolone acetonide

ACTIVE COMPARATOR
Drug: intravitreal triamcinolone injection

BRVO 4 mg dose triamcinolone acetonide

ACTIVE COMPARATOR
Drug: intravitreal triamcinolone injection

Interventions

Standard CareOTHER

CRVO: observation; BRVO: standard care

BRVO standard careCRVO Observation
intravitreal triamcinolone injectionDRUG

1 mg dose

BRVO 1 mg dose triamcinolone acetonideCRVO 1 mg dose triamcinolone acetonide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53711, United States

Location

Related Publications (15)

  • Bhavsar AR, Ip MS, Glassman AR; DRCRnet and the SCORE Study Groups. The risk of endophthalmitis following intravitreal triamcinolone injection in the DRCRnet and SCORE clinical trials. Am J Ophthalmol. 2007 Sep;144(3):454-6. doi: 10.1016/j.ajo.2007.04.011.

    PMID: 17765429BACKGROUND

  • Scott IU, VanVeldhuisen PC, Oden NL, Ip MS, Blodi BA, Jumper JM, Figueroa M; SCORE Study Investigator Group. SCORE Study report 1: baseline associations between central retinal thickness and visual acuity in patients with retinal vein occlusion. Ophthalmology. 2009 Mar;116(3):504-12. doi: 10.1016/j.ophtha.2008.10.017. Epub 2009 Jan 22.

    PMID: 19167078BACKGROUND

  • Scott IU, Blodi BA, Ip MS, Vanveldhuisen PC, Oden NL, Chan CK, Gonzalez V; SCORE Study Investigator Group. SCORE Study Report 2: Interobserver agreement between investigator and reading center classification of retinal vein occlusion type. Ophthalmology. 2009 Apr;116(4):756-61. doi: 10.1016/j.ophtha.2008.11.015.

    PMID: 19344824BACKGROUND

  • Ip MS, Oden NL, Scott IU, VanVeldhuisen PC, Blodi BA, Figueroa M, Antoszyk A, Elman M; SCORE Study Investigator Group. SCORE Study report 3: study design and baseline characteristics. Ophthalmology. 2009 Sep;116(9):1770-1777.e1. doi: 10.1016/j.ophtha.2009.03.022. Epub 2009 Jul 19.

    PMID: 19619896BACKGROUND

  • Domalpally A, Blodi BA, Scott IU, Ip MS, Oden NL, Lauer AK, VanVeldhuisen PC; SCORE Study Investigator Group. The Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study system for evaluation of optical coherence tomograms: SCORE study report 4. Arch Ophthalmol. 2009 Nov;127(11):1461-7. doi: 10.1001/archophthalmol.2009.277.

    PMID: 19901211BACKGROUND

  • Scott IU, Oden NL, VanVeldhuisen PC, Ip MS, Blodi BA, Antoszyk AN; SCORE Study Investigator Group. SCORE Study Report 7: incidence of intravitreal silicone oil droplets associated with staked-on vs luer cone syringe design. Am J Ophthalmol. 2009 Nov;148(5):725-732.e7. doi: 10.1016/j.ajo.2009.06.004. Epub 2009 Aug 11.

    PMID: 19674727BACKGROUND

  • Oden N, Vanveldhuisen PC, Scott IU, Ip MS; the SCORE Study Investigator Group. SCORE Study Report 8: Closed Tests for All Pair-Wise Comparisons of Means. Drug Inf J. 2010 Jul 1;44(4):405-420. doi: 10.1177/009286151004400405.

    PMID: 21660119BACKGROUND

  • Blodi BA, Domalpally A, Scott IU, Ip MS, Oden NL, Elledge J, Warren K, Altaweel MM, Kim JE, Van Veldhuisen PC; SCORE Study Research Group. Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study system for evaluation of stereoscopic color fundus photographs and fluorescein angiograms: SCORE Study Report 9. Arch Ophthalmol. 2010 Sep;128(9):1140-5. doi: 10.1001/archophthalmol.2010.193.

    PMID: 20837797BACKGROUND

  • Scott IU, VanVeldhuisen PC, Oden NL, Ip MS, Blodi BA, Hartnett ME, Cohen G; Standard Care versus COrticosteroid for REtinal Vein Occlusion Study Investigator Group. Baseline predictors of visual acuity and retinal thickness outcomes in patients with retinal vein occlusion: Standard Care Versus COrticosteroid for REtinal Vein Occlusion Study report 10. Ophthalmology. 2011 Feb;118(2):345-52. doi: 10.1016/j.ophtha.2010.06.034.

    PMID: 20926135BACKGROUND

  • Chan CK, Ip MS, Vanveldhuisen PC, Oden NL, Scott IU, Tolentino MJ, Blodi BA; SCORE Study Investigator Group. SCORE Study report #11: incidences of neovascular events in eyes with retinal vein occlusion. Ophthalmology. 2011 Jul;118(7):1364-72. doi: 10.1016/j.ophtha.2010.11.020. Epub 2011 Mar 26.

    PMID: 21440942BACKGROUND

  • Domalpally A, Peng Q, Danis R, Blodi B, Scott IU, Ip M; SCORE Study Research Group. Association of outer retinal layer morphology with visual acuity in patients with retinal vein occlusion: SCORE Study Report 13. Eye (Lond). 2012 Jul;26(7):919-24. doi: 10.1038/eye.2012.59. Epub 2012 Apr 27.

    PMID: 22538214BACKGROUND

  • Ip MS, Scott IU, VanVeldhuisen PC, Oden NL, Blodi BA, Fisher M, Singerman LJ, Tolentino M, Chan CK, Gonzalez VH; SCORE Study Research Group. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema secondary to central retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 5. Arch Ophthalmol. 2009 Sep;127(9):1101-14. doi: 10.1001/archophthalmol.2009.234.

    PMID: 19752419RESULT

  • Scott IU, Ip MS, VanVeldhuisen PC, Oden NL, Blodi BA, Fisher M, Chan CK, Gonzalez VH, Singerman LJ, Tolentino M; SCORE Study Research Group. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vision loss associated with macular Edema secondary to branch retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 6. Arch Ophthalmol. 2009 Sep;127(9):1115-28. doi: 10.1001/archophthalmol.2009.233.

    PMID: 19752420RESULT

  • Aref AA, Scott IU, Oden NL, Ip MS, Blodi BA, VanVeldhuisen PC; SCORE Study Investigator Group. Incidence, Risk Factors, and Timing of Elevated Intraocular Pressure After Intravitreal Triamcinolone Acetonide Injection for Macular Edema Secondary to Retinal Vein Occlusion: SCORE Study Report 15. JAMA Ophthalmol. 2015 Sep;133(9):1022-9. doi: 10.1001/jamaophthalmol.2015.1823.

    PMID: 26086920DERIVED

  • Scott IU, Vanveldhuisen PC, Oden NL, Ip MS, Domalpally A, Doft BH, Elman MJ, Blodi BA; SCORE Study Investigator Group. Baseline characteristics and response to treatment of participants with hemiretinal compared with branch retinal or central retinal vein occlusion in the standard care vs corticosteroid for retinal vein occlusion (SCORE) study: SCORE study report 14. Arch Ophthalmol. 2012 Dec;130(12):1517-24. doi: 10.1001/archophthalmol.2012.2728.

    PMID: 23229691DERIVED

MeSH Terms

Conditions

Macular EdemaRetinal Vein Occlusion

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Paul C. VanVeldhuisen, Ph.D.
Organization
The EMMES Corporation
score@emmes.com
301-251-1161

Study Officials

  • Michael S. Ip, M.D.

    University of Wisconsin, Madison

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2005

First Posted

March 4, 2005

Study Start

October 1, 2004

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

July 2, 2018

Results First Posted

January 19, 2011

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
to be set forth in data use agreement
Access Criteria
qualified investigators

Locations

US(1)