Macular Edema, CystoidPhase 3SCORENCT00105027

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

A Phase 3 study testing intravitreal triamcinolone injection in people with Macular Edema, Cystoid and Retinal Vein Occlusion, run by The Emmes Company, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Macular Edema, Cystoid, Retinal Vein Occlusion
What is being tested?: intravitreal triamcinolone injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 682 participants
Where: 1 siteUnited States
Study dates: Oct 2004to Feb 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin
Madison, Wisconsin, 53711

Other trials in United States

About this 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

Read the 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.

Conditions: Macular Edema, Cystoid, Retinal Vein Occlusion
Being tested: Standard Care, intravitreal triamcinolone injection
Keywords: macular edema, central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO)
Medical subject headings: Macular Edema, Retinal Vein Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard CareOther
CRVO: observation; BRVO: standard care
intravitreal triamcinolone injectionDrug
1 mg dose
intravitreal triamcinolone injectionDrug
4 mg

Study groups in NCT00105027
Study group	Role	What they receive
CRVO Observation	Active comparator	Not described Receives: Other: Standard Care
CRVO 1 mg dose triamcinolone acetonide	Active comparator	Not described Receives: Drug: intravitreal triamcinolone injection
CRVO 4 mg dose triamcinolone acetonide	Active comparator	Not described Receives: Drug: intravitreal triamcinolone injection
BRVO standard care	Active comparator	Not described Receives: Other: Standard Care
BRVO 1 mg dose triamcinolone acetonide	Active comparator	Not described Receives: Drug: intravitreal triamcinolone injection
BRVO 4 mg dose triamcinolone acetonide	Active comparator	Not described Receives: Drug: intravitreal triamcinolone injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from baseline to 12 months

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2004Feb 2009

First posted4 Mar 2005 (estimated)
Study startOct 2004
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Macular Edema, CystoidStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 682 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00105027
Sponsor's protocol ID: NEI-99
Other IDs: 5U10EY014351-05, 5U10EY014404, 5U10EY014352
Acronym: SCORE
Status last verified: May 2018
First submitted: 3 Mar 2005
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Data sets will be provided to qualified investigators under a Data Use Agreement.

Publications

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.
PubMed 17765429
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.
PubMed 19167078
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.
PubMed 19344824
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.
PubMed 19619896
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.
PubMed 19901211
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.
PubMed 19674727
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.
PubMed 21660119
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.
PubMed 20837797
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.
PubMed 20926135
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.
PubMed 21440942
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.
PubMed 22538214
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.
PubMed 19752419
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.
PubMed 19752420
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.
PubMed 26086920
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.
PubMed 23229691

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Macular Edema, Cystoid trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00105027
Acronym / sponsor ID: SCORE / NEI-99
Conditions: Macular Edema, Cystoid, Retinal Vein Occlusion
Keywords: macular edema, central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 682 participants (actual)
Lead sponsor: The Emmes Company, LLCIndustry (pharma, biotech, devices)
Collaborators: National Eye Institute (NEI), Allergan
Study start: Oct 2004
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 4 Mar 2005 (estimated)
Results: Posted 19 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard CareCRVO: observation; BRVO: standard care	Other	BRVO standard care, CRVO Observation
intravitreal triamcinolone injection1 mg dose	Drug	BRVO 1 mg dose triamcinolone acetonide, CRVO 1 mg dose triamcinolone acetonide
intravitreal triamcinolone injection4 mg	Drug	BRVO 4 mg dose triamcinolone acetonide, CRVO 4 mg dose triamcinolone acetonide

Primary outcome

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.

3 secondary outcomes

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

Results and safety

Results posted to the registry on 19 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CRVO Observation	88	73
CRVO 1 mg Dose Triamcinolone Acetonide	92	83
CRVO 4 mg Dose Triamcinolone Acetonide	91	82
BRVO Standard Care	137	121
BRVO 1 mg Dose Triamcinolone Acetonide	136	121
BRVO 4 mg Dose Triamcinolone Acetonide	138	125

Primary outcome: 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. Number. Unit: Participants

Measure	CRVO Observation n = 88	CRVO 1 mg Dose Triamcinolone Acetonide n = 92	CRVO 4 mg Dose Triamcinolone Acetonide n = 91	BRVO Standard Care n = 137	BRVO 1 mg Dose Triamcinolone Acetonide n = 136	BRVO 4 mg Dose Triamcinolone Acetonide n = 138
Value	5	22 (-6.4 to 4.1)	21 (-6.3 to 4.0)	35 (1.1 to 7.3)	31 (2.8 to 8.6)	34 (0.9 to 7.2)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Three years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CRVO Observation	32 of 88 (36.4%)	76 of 88 (86.4%)	0 of 88
CRVO 1 mg Dose Triamcinolone Acetonide	37 of 92 (40.2%)	87 of 92 (94.6%)	1 of 92
CRVO 4 mg Dose Triamcinolone Acetonide	53 of 91 (58.2%)	89 of 91 (97.8%)	2 of 91
BRVO Standard Care	47 of 137 (34.3%)	118 of 137 (86.1%)	3 of 137
BRVO 1 mg Dose Triamcinolone Acetonide	49 of 136 (36%)	132 of 136 (97.1%)	2 of 136
BRVO 4 mg Dose Triamcinolone Acetonide	79 of 138 (57.2%)	133 of 138 (96.4%)	2 of 138

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17765429Bhavsar 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.
Background: PubMed 19167078Scott 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.
Background: PubMed 19344824Scott 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.
Background: PubMed 19619896Ip 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.
Background: PubMed 19901211Domalpally 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.
Background: PubMed 19674727Scott 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.
Background: PubMed 21660119Oden 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.
Background: PubMed 20837797Blodi 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.
Background: PubMed 20926135Scott 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.
Background: PubMed 21440942Chan 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.
Background: PubMed 22538214Domalpally 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.
Results publication: PubMed 19752419Ip 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.
Individual participant dataSharing planned: Yes. Data sets will be provided to qualified investigators under a Data Use Agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael S. Ip, M.D. study chair

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing intravitreal triamcinolone injection in people with Macular Edema, Cystoid and Retinal Vein Occlusion, run by The Emmes Company, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00105027, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.