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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Macular Edema, Cystoid Retinal Vein Occlusion
Interventions:	Other: Standard Care Drug: intravitreal triamcinolone injection

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between November 8, 2004, and February 29, 2008, 271 patients with CRVO were enrolled from 66 clinical sites and 411 patients with BRVO were enrolled from 75 clinical sites across the United States. Participant flow data are reported for the primary outcome measure (12 months).

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Between November 8, 2004, and February 29, 2008, 271 patients with CRVO were enrolled from 66 clinical sites and 411 patients with BRVO were enrolled from 75 clinical sites across the United States.

Participant flow data are reported for the primary outcome measure (12 months).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
CRVO Observation	Standard care consists of observation of the macular edema.
CRVO 1 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
CRVO 4 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
BRVO Standard Care	Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
BRVO 1 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
BRVO 4 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).

Participant Flow: Overall Study

	CRVO Observation	CRVO 1 mg Dose Triamcinolone Acetonide	CRVO 4 mg Dose Triamcinolone Acetonide	BRVO Standard Care	BRVO 1 mg Dose Triamcinolone Acetonide	BRVO 4 mg Dose Triamcinolone Acetonide
STARTED	88	92	91	137	136	138
COMPLETED	73	83	82	121	121	125
NOT COMPLETED	15	9	9	16	15	13

Baseline Characteristics

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Reporting Groups

	Description
CRVO Observation	Standard care consists of observation of the macular edema.
CRVO 1 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
CRVO 4 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
BRVO Standard Care	Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
BRVO 1 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
BRVO 4 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).

Baseline Measures

	CRVO Observation	CRVO 1 mg Dose Triamcinolone Acetonide	CRVO 4 mg Dose Triamcinolone Acetonide	BRVO Standard Care	BRVO 1 mg Dose Triamcinolone Acetonide	BRVO 4 mg Dose Triamcinolone Acetonide	Total
Number of Participants [units: participants]	88	92	91	137	136	138	682
Age [units: participants]
<=18 years	0	0	0	0	0	0	0
Between 18 and 65 years	25	35	34	62	54	55	265
>=65 years	63	57	57	75	82	83	417
Age [units: years] Mean ± Standard Deviation	69.2 ± 12.8	67.4 ± 12.4	67.5 ± 12.0	66.9 ± 11.5	67.2 ± 11.5	68.1 ± 10.6	67.7 ± 11.2
Gender [units: participants]
Female	40	43	40	71	68	63	325
Male	48	49	51	66	68	75	357
Region of Enrollment [units: participants]
United States	88	92	91	137	136	138	682

Outcome Measures

1. Primary:

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 ]

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2. Secondary:

Changes From Baseline in Best-corrected ETDRS Visual Acuity Score [ Time Frame: 36 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography [ Time Frame: 36 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Adverse Ocular Outcomes [ Time Frame: 36 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Paul C. VanVeldhuisen, Ph.D.
Organization: The EMMES Corporation
phone: 301-251-1161
e-mail: score@emmes.com

Publications of Results:

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.

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.

Other 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.

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. Epub 2009 Jan 22.

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.

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. Epub 2009 Jul 19.

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.

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. Epub 2009 Aug 11.

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head ), Allergan, Inc.
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:	March 22, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration